date_received int64 20.2M 20.3M | event_type stringclasses 5
values | brand_name stringlengths 1 167 ⌀ | generic_name stringlengths 2 126 ⌀ | event_text stringlengths 27 181k |
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20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: DTBB1D1 CRTD IMPLANT DATE (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING LEADING TO THE EARLY TERMINATION OF THE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: SEDR01 IPG, IMPLANTED: (B)(6) 2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING THRESHOLDS AND UNDER-SENSING. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE RA LEAD AND RV LEAD WERE INACTIVATED AND REPLACED BY A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT PHYSICIAN MADE A MEDICAL JUDGEMENT TO REPLACE THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO WHEN REPLACING THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE NO PRODUCT PERFORMANCE ISSUES REPORTED WITH THE IPG. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK APPROXIMATELY FIVE WEEKS POST IMPLANT A PACING FAILURE, SENSING FAILURE AND DISLODGEMENT WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. X-RAY CONFIRMED THE LEAD HAD BEEN PULLED UP TO THE SUPERIOR VENA CAVA (SVC) DUE TO A LOOSE ANCHORING SLEEVE. THE LEAD WAS REPROGRAMMED AND THEN EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: W3DR01 IPG, IMPLANTED: (B)(6) 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT REPORTED NOT FEELING WELL. FOLLOWING REVIEW OF THE ECHO CARDIOGRAM THE PHYSICIAN THOUGHT THE RIGHT VENTRICULAR (RV) LEAD MAY HAVE DISLODGED INTO THE LEFT VENTRICLE. FURTHER REVIEW CONFIRMED THE LEAD HAD BEEN PLACED IN THE ARTERIAL SYSTEM. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT RV LEAD WAS REPLACED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SMALL R WAVES ONE DAY AFTER IMPLANT. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSURE SENSE LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT A DAY AFTER IMPLANT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND EXHIBITED HIGH THRESHOLDS, LOSS OF CAPTURE AND HIGH IMPEDANCE. THE RV LEAD WAS EXPLANTED AND REPLACED . NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | SERENA QUAD CRT-P MRI SURESCAN | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPLANT AREA WAS SORE AND SWOLLEN AND HAD A BUMP AND SCAR TISSUE. THE DEVICE HAD REPORTEDLY GONE UNDER THE PATIENT'S ARMPIT. THE PATIENT'S PECTORAL MUSCLES ON BOTH SIDES WERE HURTING AND THE PATIENT ALSO HAD CHEST PAIN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT THE RV LEAD HAD NO CAPTURE AS IT HAD PULLED OUT OF THE RV CHAMBER. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT DURING IMPLANT THE RIGHT ATRIAL (RA) LEAD REPEATEDLY DISLODGED, IT WAS NOTED THAT THE HELIX APPEARED TO NOT BE FULLY EXTENDED, PLACING WAS TRIED MULTIPLE TIMES TO NO AVAIL. THE RA LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | AZURE S DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST IMPLANT THE PATIENT EXPERIENCED POCKET INFECTION. THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED AND REMAIN IN THE PATIENT, WHEREAS THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. CULTURES WERE TAKEN AND THE PATIENT WAS ADMINISTERED A COURSE OF ANTIBIOTICS FOR THE NEXT SEVERAL WEEKS. ONCE THE INFECTION IS CLEAR A NEW IPG WILL BE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST IMPLANT THE PATIENT EXPERIENCED POCKET INFECTION. THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE CAPPED AND REMAIN IN THE PATIENT, WHEREAS THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. CULTURES WERE TAKEN AND THE PATIENT WAS ADMINISTERED A COURSE OF ANTIBIOTICS FOR THE NEXT SEVERAL WEEKS. ONCE THE INFECTION IS CLEAR A NEW IPG WILL BE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT AN ALERT WAS NOTED FOR UNDEFINED HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. A POLARITY SWITCH WAS ALSO NOTED. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS A HIS BUNDLE LEAD. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT POST OPERATIVELY THE RIGHT ATRIAL (RA) LEAD EXHIBITED VARIABLE AND UNDERSENSING. IT WAS ALSO REPORTED THAT THE HELIX APPEARED TO BE BENT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS INDICATED THE HELIX OF THE LEAD WAS EXTRINSICALLY BENT. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYED AN INACCURATE ATRIAL IMPEDANCE MEASUREMENT. THE RA LEAD AND IPG REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE OF THE ATRIAL PACING LEAD WAS BELOW THE EXPECTED LOWER RANGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | AZURE XT DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYED AN INACCURATE ATRIAL IMPEDANCE MEASUREMENT. THE RA LEAD AND IPG REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A FALSE ALERT FOR LEAD IMPEDANCE OUT OF RANGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH SHORT INTERVALS AND INCREASED IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE ATTEMPTED RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING THRESHOLDS AND WOULD NOT PACE IN MULTIPLE LOCATIONS. THE LEAD ALSO EXHIBITED HIGH PACING IMPEDANCE. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: 0157 LEAD, IMPLANTED ON (B)(6) 2002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THERE WAS A POSSIBLE FRACTURE ON THE RIGHT ATRIAL (RA) LEAD AND IT ALSO EXHIBITED HIGH AND UNDEFINED IMPEDANCE READINGS, IT WAS NOTED ON AN X-RAY THAT AS THE PATIENT GREW THE LEAD APPEARED TO STRETCH TO THE POINT OF FRACTURE. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: W2DR01, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT ID: 5076-58, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERFORATION. THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION AFTER A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED LEAD VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVER-SENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVER-SENSING. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF MULTIPLE 'SHOCKS' ON A DAILY BASIS. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION AFTER A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED LEAD VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | CLARIA MRI QUAD CRT-D SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION AFTER A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED LEAD VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD IMPLANTED: (B)(6) 2009, DTBA1D1 ICD IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE WARNING DUE TO HIGH VALUES. THE THERAPIES WERE PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE. THE DEVICE WAS REPROGRAMMED AND CONSEQUENTLY THE RV LEAD WAS TURNED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN THRESHOLDS. A CHEST X-RAY REVEALED THERE WAS A SLIGHT CHANGE IN THE POSITION OF THE RV LEAD. THE PHYSICIAN CONCLUDED A MICRO-PERFORATION HAD OCCURRED. THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION RESULTING IN TAMPONADE. THE EFFUSION WAS DRAINED AND THE LEAD WAS REPOSITION. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT VENTRICULAR TO VENTRICULAR INTERVALS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ON (B)(6) 2020: IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND CARDIAC ARREST. IT WAS ALSO FURTHER RE PORTED THAT THE RV LEAD EXHIBITED UNDER-SENSING. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASE IN IMPEDANCE, HIGH IMPEDANCE, POLARITY SWITCH, INCREASE IN THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS CAPPED AND REPLACED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | AMPLIA MRI QUAD CRT-D SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN INAPPROPRIATE SHOCK TO THE PATIENT. THE SHOCK WAS DELIVERED DUE TO OVERSENSING AND NOISE. ADDITIONALLY AN ALERT TRIGGERED DUE TO COUNTS TO THE SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED TACHYCARDIA. THIS EVENT WAS CORRELATED TO THE PATIENT'S USE OF PULSED ELECTROMAGNETIC FIELD (PEMF) THERAPY WITH ELECTRODE PADS PLACED ON THE PATIENT'S CHEST SIMULTANEOUSLY TO THE ALERT AND SHOCK EVENT. PROVOCATIVE TESTING WAS ADMINISTERED AND SHOWED NO OVERSENSING OR OTHER ABNORMALITIES. THE PATIENT WAS ADVISED TO DISCONTINUE USE OF PEMF THERAPY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT UNDERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | AZURE XT DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A TELEMETRY ISSUE. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE VALUES. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PERSISTENT LOW R WAVES DURING THE IMPLANT ATTEMPT. AN ALTERNATE LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | REVO MRI SURESCAN | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FULL RESET. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT VENTRICULAR TO VENTRICULAR INTERVALS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE AND HAVE REMAINED STABLE SICE THE IPG REPROGRAMMING. THE RA AND RV LEADS REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FULL RESET. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT VENTRICULAR TO VENTRICULAR INTERVALS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE AND HAVE REMAINED STABLE SICE THE IPG REPROGRAMMING. THE RA AND RV LEADS REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2020 THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE. THE RA AND RV LEADS REMAIN IN USE AND HAVE REMAINED STABLE SINCE THE IPG REPROGRAMMING. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A FULL POWER ON RESET OCCURRED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | IT WAS REPORTED THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THE RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | IMPLANTABLE LEAD | (B)(4). IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL PATIENT ISSUES WERE REPORTED. PATIENT CODE 3191 CAPTURES THE ADDITIONAL SURGICAL PROCEDURE THAT WAS PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS. X-RAY INSPECTION AND CONTINUITY TESTING SHOWED CONDUCTORS WERE INTACT. VISUAL INSPECTION SHOWED SETSCREW MARKS ON THE TERMINAL PIN WERE IN THE CORRECT LOCATION. INSPECTION SHOWED STRETCHED-OUT COILS AT THE LEAD TIP AND A STRETCHED-OUT HELIX, WHICH WAS LIKELY EXPLANT DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. THE PHYSICIAN ROTATED THE FIXATION TOOL IN THE WRONG DIRECTION WHEN DEPLOYING THE HELIX DURING IMPLANT. NO ADDITIONAL PATIENT ISSUES WERE REPORTED. |
20,200,427 | Malfunction | ACCOLADE MRI EL DR | IMPLANTABLE DEVICE | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED SENSING OF CHRONIC HIGH ATRIAL RATES WHICH MAY IMPACT BATTERY LONGEVITY OVER TIME. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. IT WAS REPORTED THAT THIS PACEMAKER DEVICE BATTERY LONGEVITY WAS DECREASING FASTER THAN EXPECTED. A REVIEW OF THE DEVICE DATA BY BOSTON SCIENTIFIC ENGINEERING DETERMINED THAT THE DEVICE IS SENSING THE PATIENTS HIGH ATRIAL RATES RESULTING IN HIGH BATTERY POWER CONSUMPTION. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED GUIDANCE TO CONSIDER PROGRAMMING THE DEVICE TO A NON-ATRIAL BASED BRADY MODE AND PROGRAMMING OFF THE ATRIAL LEAD SENSING TO REDUCE POWER CONSUMPTION. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. OBJECTIVE EVIDENCE FROM FIELD DETERMINED THAT PERFORATION OCCURRED. PERFORATION IS A KNOWN POSSIBLE COMPLICATION OF AN IMPLANTABLE LEAD. IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS AND LOSS OF CAPTURE. PATIENT WAS ADMITTED TO HOSPITAL FOR ABDOMINAL DISCOMFORT. AN X-RAY WAS PERFORMED AND CONFIRMED THE RV LEAD DISLODGED, PERFORATED THE HEART AND WAS NEAR THE DIAPHRAGM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | AS NO FURTHER INFORMATION REGARDING THIS EVENT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED. IT WAS REPORTED THAT A PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS HOSPITALIZED AFTER RECEIVING AN INAPPROPRIATE SHOCK. REVIEW OF THE DEVICE DATA INDICATED THERE WAS OVERSENSING, NOISE, AND LOW MORPHOLOGY MEASUREMENTS NOTED. NO CHANGES WERE MADE AND THE S-ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | (B)(4). IT WAS REPORTED THAT THERE APPEARED TO BE SOME FORM OF LOSS OF CAPTURE ON THIS NEWER IMPLANTED RIGHT VENTRICULAR (RV) LEAD. THE INTRINSIC AMPLITUDE HAD DECREASED, AND THE PACE IMPEDANCE WAS STABLE. ADDITIONAL INFORMATION WAS REPORTED, INDICATING THAT THIS RV LEAD WAS REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED. IT WAS REPORTED THAT THERE APPEARED TO BE SOME FORM OF LOSS OF CAPTURE ON THIS NEWER IMPLANTED RIGHT VENTRICULAR (RV) LEAD. THE INTRINSIC AMPLITUDE HAD DECREASED, AND THE PACE IMPEDANCE WAS STABLE. ADDITIONAL INFORMATION WAS REPORTED, INDICATING THAT THIS RV LEAD WAS REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED. ADDITIONAL INFORMATION WAS REPORTED INDICATING THAT THIS LEAD WAS ULTIMATELY REMOVED AND REPLACED AS A RESULT OF A CHANGE IN THRESHOLD AND LOSS OF CAPTURE. THIS WAS THOUGHT TO BE RELATED TO THE PATIENT CONDITION AND NOT A REFLECTION OF A PRODUCT ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RETURNED. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED. THE PATIENT CODE 3191 ACCOUNTS FOR THE SURGICAL INTERVENTION THAT OCCURRED. |
20,200,427 | Malfunction | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED SENSING OF CHRONIC HIGH ATRIAL RATES WHICH MAY IMPACT BATTERY LONGEVITY OVER TIME. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. IT WAS REPORTED THAT REVIEW OF THIS PACEMAKER FOUND THAT SIGNAL ARTIFACT MONITOR WAS SENSING ATRIAL FIBRILLATION (AF) THAT TRIGGERED THE SENSING VECTOR TO SWITCH TO THE VENTRICLE, THEN ULTIMATELY DISABLING THE MINUTE VENTILATION SENSOR. THERE WERE ALSO ALLEGATIONS OF HIGH ATRIAL RATE SENSING DUE TO ATRIAL FIBRILLATION CAUSING AN INCREASE IN POWER CONSUMPTION THAT HAD DROPPED THE LONGEVITY OF THIS PACEMAKER IMPLANTED IN 2017 TO ONLY 3.5 YEARS REMAINING. THE DEVICE WAS REPROGRAMMED TO PROVIDE THERAPY IN THE VENTRICLE ONLY (ATRIAL LEAD OFF) AND PROGRAMMED MV BACK ON. THIS DEVICE REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | CAPSURE FIX MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FULL RESET. THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT VENTRICULAR TO VENTRICULAR INTERVALS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE. THE RA AND RV LEADS REMAIN IN USE AND HAVE REMAINED STABLE SINCE THE IPG REPROGRAMMING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE ADDITIONAL INFORMATION REGARDING THE FAILURE TO RESOLVE THE TELEMETRY ISSUE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE ADDITIONAL INFORMATION REGARDING THE FAILURE TO RESOLVE THE TELEMETRY ISSUE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. IT WAS REPORTED THIS PATIENT HAD DIFFICULTY WITH TELEMETRY WITH THEIR PROGRAMMER AT HOME. THE PATIENT WAS BROUGHT INTO THE CLINIC SHORTLY AFTER AND THERE WERE ADDITIONAL DIFFICULTIES INTERROGATING THE DEVICE WITH THE FIELD REPRESENTATIVES PROGRAMMER. TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS. THE FIELD REPRESENTATIVE ADVISED THE PHYSICIAN TO CONTINUE WITH REMOTE MONITORING AND HAVE THE PATIENT FOLLOW-UP NORMALLY. THE SYSTEM IS STILL CURRENTLY IN SERVICE. NO ADVERSE EVENTS WERE REPORTED AT THIS TIME. THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE COMPLETED EVALUATION OF THIS PRODUCT. THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION IDENTIFIED NO ANOMALIES. DURING INITIAL TESTING, IT WAS NOTED THE BEHAVIOR OF THE DEVICE POINTED TO A POSSIBLE ISSUE WITH THE RADIO FREQUENCY (RF) HARDWARE STARTUP AND, AS SUCH, THE RF WAKE UP PERIODS WERE TESTED. INITIALLY, ALL WAKE UP PERIODS DURING THIS TESTING WERE CONSIDERED WITHIN THE ACCEPTABLE OPERATION THRESHOLD (I.E., THE RESULTS DID NOT FIND ANY CAPTURED PULSES THAT HAD A PULSE WIDTH OF LESS THAN 2MS); HOWEVER, THE MAXIMUM PULSE WIDTHS APPEARED TO BE DECREASING AS TEMPERATURES WERE INCREASED. THIS BEHAVIOR IS CONSISTENT WITH A SHORTENED TELEMETRY WAKE-UP PULSE BEHAVIOR ('RADIOFREQUENCY/RF WAKE-UP PERIOD') ASSOCIATED WITH THE CRYSTAL OSCILLATOR WITHIN THE RF CIRCUIT. ALTHOUGH THE S-ICD WAS ABLE TO BE SUCCESSFULLY INTERROGATED IN THE LABORATORY SETTING, THE VARYING AND INTERMITTENT TIMING DELAYS OBSERVED DURING TESTING LIKELY CAUSED OR CONTRIBUTED TO THE INABILITY TO ESTABLISH TELEMETRY WHILE IMPLANTED. |
20,200,427 | Malfunction | PROPONENT MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED SENSING OF CHRONIC HIGH ATRIAL RATES WHICH MAY IMPACT BATTERY LONGEVITY OVER TIME. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. IT WAS REPORTED, DURING A FOLLOW UP THERE WERE CONCERNS REGARDING PREMATURE BATTERY DEPLETION OF THIS PACEMAKER. DATA ANALYSIS WAS PERFORMED, AND IT WAS FOUND THAT THIS PATIENT WAS IN ATRIAL FIBRILLATION (AF) AND THE INCREASE IN POWER CONSUMPTION WAS DUE TO HIGH RATE ATRIAL SENSING. IN ADDITION, THE PATIENT ALSO HAS SIGNAL ARTIFACT MONITOR (SAM) INSTALLED AND ENABLED. THE SAM PATCH CAN ALSO CONSUME ADDITIONAL POWER IN THE PRESENCE OF HIGH ATRIAL RATE SENSING. TECHNICAL SERVICES (TS) RECOMMENDED METHODS TO REDUCE THE HIGH RATE ATRIAL SENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE. |
20,200,427 | Malfunction | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THE LEAD SAFETY SWITCH (LSS) HAD BEEN TRIGGERED FOR THIS SYSTEM DUE TO AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS ON THE ATRIAL CHANNEL. NOISE AND OVERSENSING RESULTED IN INAPPROPRIATE ATRIAL TACHYCARDIA RESPONSE (ATR) EPISODES. ADDITIONALLY, AN ATRIAL THRESHOLD ISSUE WAS NOTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOCUMENTED AND DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. THE CALLER STATED THE PATIENT IS NOT DEPENDENT AND THEY DO NOT WANT TO BRING THE PATIENT IN DUE TO CORONAVIRUS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A MALFUNCTION OR INADEQUATE LEAD-TO-DEVICE CONNECTION; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. THIS SUPPLEMENTAL REPORT IS BEING FILED TO UPDATE THE INVESTIGATION CONCLUSION CODE AND ADDITIONAL MANUFACTURING NARRATIVE. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | IT WAS REPORTED THAT THIS RIGHT ATRIAL LEAD WITH ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACING LEAD IMPEDANCES GREATER THAN 3000 OHMS, OVERSENSING AND NOISE. THE DEVICE STORED EPISODES OF ATRIAL TACHY RESPONSE (ATR) DUE TO NOISE AND OVERSENSING. TECHNICAL SERVICES PROVIDED ADDITIONAL TESTS THAT CAN BE DONE AT THE NEXT DEVICE FOLLOW UP. SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT AND REPLACE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | PROPONENT MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED SENSING OF CHRONIC HIGH ATRIAL RATES WHICH MAY IMPACT BATTERY LONGEVITY OVER TIME. PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. IT WAS REPORTED, DURING A FOLLOW UP THIS PACEMAKER EXHIBITED PBD. DATA ANALYSIS WAS REVIEWED BY TECHNICAL SERVICES (TS). IT WAS DETERMINED THAT THE PACEMAKER WAS DEPLETING AS EXPECTED. THE ELEVATED POWER IS A RESULT OF PERSISTENT ATRIAL FIBRILLATION. INCREASED POWER CONSUMPTION IN THE PRESENCE OF HIGH ATRIAL RATES IS EXPECTED BEHAVIOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE. |
20,200,427 | Injury | ESSENTIO MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A PRODUCT PERFORMANCE ISSUE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REMOVE THE DEVICE AND IMPLANT A NEW PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PATIENT CODE 3191 CAPTURES THE REPORTABLE EVENT OF SURGERY. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE PASSED MECHANICAL AND ELECTRICAL TESTS AND IS FUNCTIONING NORMALLY. IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A PRODUCT PERFORMANCE ISSUE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION TO REMOVE THE DEVICE AND IMPLANT A NEW PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | IT WAS REPORTED THAT THIS PATIENT HAS A HISTORY OF MANY TREATED EPISODES. SOME OF THESE SHOCKS WERE A RESULT OF OVERSENSING OF NOISY SIGNALS WITH LOWER AMPLITUDES. IT IS NOTED THAT DUE TO THE LARGE NUMBER OF SHOCKS THAT THE PATIENT HAS RECEIVED THE DEVICE HAS DEPLETED AND IS EXHIBITING END OF LIFE (EOL). THESE INAPPROPRIATE SHOCKS COULD HAVE CONTRIBUTED TO THE DEVICE DEPLETING FASTER THEN EXPECTED. THE PATIENT'S SYSTEM WAS TURNED OFF AT THIS TIME WHILE HAVING AN SURGICAL PROCEDURE. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. |
20,200,427 | Malfunction | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK WHILE BICYCLING DUE TO OVERSENSING OF NOISE. THE NOISE WAS ABLE TO BE REPRODUCED ON ALL THREE VECTORS WHEN THE PATIENT PUSHED THEIR HANDS TOGETHER AND WAS DETERMINED TO BE DUE TO MYOPOTENTIALS. THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS IN THE PAST. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE OPTION OF REPROGRAMMING VECTORS OR ZONES. THE FIELD REPRESENTATIVE NOTED THAT THE CURRENT VECTOR HAD GOOD QRS TO T WAVE SENSING RATIOS. IT WAS FURTHER NOTED THAT THE PATIENT HAS A THROMBUS. SINCE THE PATIENT WAS TRAVELING IN THE UNITED STATES FROM A DIFFERENT COUNTRY, THE EMERGENCY ROOM PHYSICIAN DECIDED NOT TO REPROGRAM THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND REFERRED THE PATIENT TO THEIR FOLLOWING PHYSICIAN WHEN THEY RETURN TO THEIR HOME COUNTRY. THE S-ICD AND ELECTRODE REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | IT WAS REPORTED THAT THIS DEVICE HAD EXHIBITED A LONG CHARGE (LC) CODE. THE EPISODE WAS REVIEWED THE INDICATED THAT THERE WAS SENSING ISSUE WITH A SHOCK IMPEDANCE THAT WAS LOW AND OUT OF RANGE. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR IMAGING WHICH CONFIRMED THAT THE ELECTRODE WAS TWIDDLED IN THE DEVICE POCKET. THE SYSTEM WAS DEACTIVATED AND THE PATIENT ELECTED TO LEAVE THE HOSPITAL AGAINST MEDICAL ADVISE. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE DEVICE CONCLUSION CODE INFORMATION. THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE DEVICE CONCLUSION CODE INFORMATION. |
20,200,427 | Malfunction | INGEVITY MRI | IMPLANTABLE LEAD | NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE. IT WAS REPORTED THAT DURING DEVICE DATA REVIEW THIS RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND NOISE. THIS LEAD REMAINS IN SERVICE AND WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF COMPROMISED CAPACITORS. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITORS WERE COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING A SUBSET OF PACEMAKERS IN THE ACCOLADE PRODUCT FAMILY THAT HAS AN ELEVATED POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS DEVICE IS NOT PART OF THE HYDROGEN INDUCED PREMATURE DEPLETION ADVISORY POPULATION. IT WAS REPORTED THAT A SIGNIFICANT DECREASE IN BATTERY LONGEVITY WAS NOTED BETWEEN NORMAL FOLLOW UPS. BOSTON SCIENTIFIC TECHNICAL SERVICES WERE CONTACTED AND CONFIRMED THE DEVICE WAS PREMATURELY DEPLETING AND RECOMMENDED DEVICE REPLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE WITH NO ADDITIONAL ADVERSE CONSEQUENCES. THE DEVICE WAS SUBSEQUENTLY RETURNED FOR ANALYSIS. |
20,200,427 | Malfunction | INGEVITY MRI | IMPLANTABLE LEAD | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS UNABLE TO BE SUCCESSFULLY IMPLANTED DUE TO UNKNOWN REASONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | THIS PRODUCT IS EXPECTED TO BE RETURNED BACK FROM THE FIELD FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLD AND IMPEDANCE MEASUREMENTS IN MULTIPLE IMPLANT POSITIONS. HELIX ROTATION ISSUES WERE ALSO NOTED. THE RA LEAD WAS REMOVED AND REPLACED PRIOR TO POCKET CLOSURE AND WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS APPROXIMATELY 5.5 CENTIMETERS (CM) FROM THE TERMINAL END. THE HELIX WAS IN A RETRACTED POSITION WITH DRIED BLOOD/BODY FLUID IN THE HELIX HOUSING AND TIP REGION. THE HELIX MECHANISM COULD NOT BE TESTED DUE TO THE DRIED BLOOD THUS CONFIRMING THE HELIX DIFFICULTY ALLEGATION MADE IN THE FIELD. THE LEAD PASSED A CONTINUITY AND HIPOT TEST WHICH CONFIRMED THE ELECTRICAL AND INNER INSULATION INTEGRITY. THUS THE HIGH CAPTURE AND HIGH IMPEDANCE ALLEGATIONS COULD NOT BE CONFIRMED THROUGH TESTING. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLD AND IMPEDANCE MEASUREMENTS IN MULTIPLE IMPLANT POSITIONS. HELIX ROTATION ISSUES WERE ALSO NOTED. THE RA LEAD WAS REMOVED AND REPLACED PRIOR TO POCKET CLOSURE AND WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | AS NO FURTHER INFORMATION REGARDING THIS EVENT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED. IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD DELIVERED AN INAPPROPRIATE SHOCK DUE TO POTENTIAL AIR BUBBLE OVERSENSING. THE S-ICD WAS REPROGRAMMED FROM THE PRIMARY TO THE SECONDARY VECTOR AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | ESSENTIO MRI EL DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED FOLLOWING DEVICE RETURN AND COMPLETION OF ANALYSIS, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IT WAS REPORTED THAT PRIOR TO IMPLANT, THIS BOXED PACEMAKER WAS INTERROGATED AND FOUND TO BE IN SAFETY MODE. TECHNICAL SERVICES (TS) RECOMMENDED RETURNING THE DEVICE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE CLINICALLY OBSERVED ERROR MESSAGE WAS REPRODUCED. MEMORY REVIEW CONFIRMED THAT THE DEVICE UNDERWENT A RESET DUE TO MEMORY CORRUPTION WHICH RESULTED IN THE OBSERVED ERROR MESSAGE. FOLLOWING THE RESET, THE DEVICE REVERTED TO A SAFETY MODE WITH LIMITED PROGRAMMABILITY WITH SINGLE CHAMBER PACING AVAILABLE. DETAILED ANALYSIS FOUND THE RESET WAS DUE TO AN ANOMALY WITHIN THE DIGITAL INTEGRATED CIRCUIT. IT WAS REPORTED THAT PRIOR TO IMPLANT, THIS BOXED PACEMAKER WAS INTERROGATED AND FOUND TO BE IN SAFETY MODE. TECHNICAL SERVICES (TS) RECOMMENDED RETURNING THE DEVICE. THIS DEVICE WAS LATER RETURNED AND ANALYSIS WAS COMPLETED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER/OUTER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. IT WAS REPORTED THAT THIS PATIENT NEEDED TO SURGICALLY RECEIVE A TEMPORARY PACEMAKER DURING THE UPGRADE PROCEDURE. WHEN THE PHYSICIAN CONNECTED THIS RIGHT ATRIAL (RA) LEAD, THE PACING IMPEDANCE WAS HIGH AND OUT OF RANGE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RA LEAD TO RESOLVE THE EVENT. THE LEAD WAS RETURNED FOR ANALYSIS. THE PATIENT WAS STABLE WITH NO ADDITIONAL ADVERSE CONSEQUENCES. |
20,200,427 | Injury | ESSENTIO MRI SR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS PRODUCT HAS BEEN RETURNED BACK FROM THE FIELD FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS. IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE PREMATURELY DEPLETING. REVIEW OF DEVICE DATA CONFIRMED THE BATTERY WAS DEPLETING FASTER THAN EXPECTED AND DEVICE REPLACEMENT WAS RECOMMENDED. SURGICAL INTERVENTION WAS LATER PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF COMPROMISED CAPACITORS. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITORS WERE COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING A SUBSET OF PACEMAKERS IN THE ACCOLADE PRODUCT FAMILY THAT HAS AN ELEVATED POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS DEVICE IS NOT PART OF THE HYDROGEN INDUCED PREMATURE DEPLETION ADVISORY POPULATION. IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE PREMATURELY DEPLETING. REVIEW OF DEVICE DATA CONFIRMED THE BATTERY WAS DEPLETING FASTER THAN EXPECTED AND DEVICE REPLACEMENT WAS RECOMMENDED. SURGICAL INTERVENTION WAS LATER PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL EXAMINATION CONFIRMED THE COMPLETE LEAD WAS RETURNED, SEVERED IN TWO SEGMENTS. EXAMINATION ALSO NOTED THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD WAS PRESENT IN THE HELIX HOUSING. RESISTANCE TESTING CONFIRMED THE TWO SEGMENTS WERE ELECTRICALLY CONTINUOUS. AN X-RAY OF EACH LEAD SEGMENT NOTED A SLIGHTLY STRETCHED CATHODE INNER COIL, NEAR THE TIP; HOWEVER, THIS FINDING WOULD NOT HAVE IMPACTED PACING THRESHOLD MEASUREMENTS OR SENSING ABILITIES. ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND HIGH THRESHOLDS, POST WOUND CLOSURE. ATTEMPTS WERE MADE TO REPOSITION THE LEAD WERE UNSUCCESSFUL. A DIFFERENT LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF COMPROMISED CAPACITORS. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITORS WERE COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING A SUBSET OF PACEMAKERS IN THE ACCOLADE PRODUCT FAMILY THAT HAS AN ELEVATED POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS DEVICE IS NOT PART OF THE HYDROGEN INDUCED PREMATURE DEPLETION ADVISORY POPULATION. IT WAS REPORTED THAT PREMATURE DEPLETION OF THIS DEVICE WAS SUSPECTED DUE TO AN INCREASE IN POWER CONSUMPTION. A DOWNLOAD OF THE DEVICE DATA BY A BOSTON SCIENTIFIC ENGINEER CONFIRMED THE POWER CONSUMPTION OF THIS DEVICE HAD BEEN INCREASING DURING THE PAST YEAR AND IS EXPECTED TO CONTINUE TO INCREASE. DEVICE EXPLANT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND RETURNED FOR TESTING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. THIS SUPPLEMENTAL REPORT IS BEING FILED TO UPDATE THE DEVICE IMPLANT DATE AND EXPLANT DATE. |
20,200,427 | Injury | VISIA AF MRI XT VR SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISCRIMINATOR SUSPENDED SHOCK UNTIL TIME-OUT OCCURRED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | EMBLEM MRI S-ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) OVERSENSED MYOPOTENTIAL NOISE RESULTING IN INAPPROPRIATE SHOCKS ON TWO DIFFERENT OCCASIONS. THERE WAS ALSO EVIDENCE OF LOW AMPLITUDES. AT THE TIME OF THE SHOCKS THE PATIENT WAS LYING DOWN AND USING THE BATHROOM. IT WAS NOTED THAT THE PATIENT IS IN CHRONIC RENAL FAILURE AND UNDERGOES HEMODIALYSIS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING POSTURAL BASED ISOMETRICS AND PROGRAMMING OPTIMIZATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THAT ADDITIONAL INAPPROPRIATE SHOCK WAS DELIVERED. A REVIEW OF THE THERAPY LOGBOOK NOTED THAT THE SHOCKS DO NOT CORRELATE TO ANY HEMODIALYSIS SESSION. THE AUTOMATIC SCREENING TOOL WAS PERFORMED AT THE CURRENT SYSTEM LOCATION AND FAILED IN ALL VECTORS. TS REVIEWED THE ELECTROGRAMS IN SEVERAL TREATED AND UNTREATED EPISODES AND INDICATED THAT THERE APPEARS THERE HAS BEEN A CHANGE IN THE PATIENT CONDITION WHICH REMARKABLY AFFECTS THE DEVICE'S SENSING OPTIONS. THERE WERE MANY DIFFERENT MORPHOLOGIES OVER THE YEARS THIS SYSTEM HAS BEEN IMPLANT WHICH MIGHT BE RELATED TO CHANGING PATIENT CONDITION AND/OR SYSTEM MIGRATION. TS REQUESTED CURRENT X-RAYS AND THOSE FROM IMPLANT HOWEVER DUE TO COVID THIS HAS BEEN DELAYED. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: W4TR01 CRTP IMPLANT DATE (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT PATIENT EXPERIENCED DIZZINESS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSITION CHECK FAILURE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | INGEVITY MRI | IMPLANTABLE LEAD | (B)(4). IT WAS REPORTED THAT THE RIGHT ATRIAL (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO LEAD BODY DAMAGE. THERE WERE NO ADDITIONAL PATIENT ISSUES. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO THE LEAD NOT CAPTURING. THEN, WHILE PERFORMING THE EXPLANT, THE LEAD BROKE APART. THERE WERE NO ADDITIONAL PATIENT ISSUES. PATIENT CODE 3191 CAPTURES THE ADDITIONAL SURGICAL PROCEDURE THAT WAS PERFORMED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RECEIVED; SEVERED 587 MM FROM THE TERMINAL END. VISUAL INSPECTION REVEALED A FRACTURE, COIL DEFORMATION, LEAD BODY DAMAGE, INSULATION ABRASION, AND INSULATION TEAR. DETAILED ANALYSIS CONFIRMED THE OUTER COIL WAS FRACTURED 260 MM FROM THE TERMINAL PIN. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION. THE REPORTED LOSS OF CAPTURE IS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY. |
20,200,427 | Injury | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED AN INAPPROPRIATE SHOCK DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING. ADDITIONALLY, THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND INCREASED SENSING INTEGRITY COUNTER (SIC). THE RV LEAD ALSO EXHIBITED AN ALERT FOR HIGH RV COIL IMPEDANCE AND HIGH PACING IMPEDANCE. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | CONCOMITANT MEDICAL PRODUCTS: 5076-58 LEAD, IMPLANT DATE: (B)(6) 2002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT DURING PROCEDURE THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE FRACTURED/FRAYED. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | PRODUCT EVENT SUMMARY: THE MEDIAL PORTION OF THE LEAD WAS RETURNED AND ANALYZED. THE ANALYSIS INDICATED THAT THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. THE ANALYST NOTED THAT THE DISTAL CONDUCTOR WAS FRACTURED BUT NO LOCATION COULD BE DETERMINED DUE TO EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED. THE LEAD WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID D314DRG ICD, IMPLANTED: (B)(6) 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND UNDERSENSING ON STORED ELECTROGRAMS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SELECTSECURE MRI SURESCAN | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT RISING THRESHOLDS WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS EXPLANTED DURING AN UPGRADE TO BI-VENTRICULAR DEFIBRILLATOR . NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | AMPLIA MRI QUAD CRT-D SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. A REPLACEMENT PROCEDURE IS PLANNED IN THE FUTURE AND WILL BE ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION APPROXIMATELY THREE WEEKS POST IMPLANT. A REPLACEMENT PROCEDURE IS PLANNED IN THE FUTURE AND WILL BE ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | ATTAIN PERFORMA S MRI SURESCAN | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION APPROXIMATELY THREE WEEKS POST IMPLANT. A REPLACEMENT PROCEDURE IS PLANNED IN THE FUTURE AND WILL BE ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | AZURE XT DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT A PARTIAL RESET WAS CONFIRMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT A DIAGNOSTIC RESET OCCURRED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL POWER ON RESET OCCURRED. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT THE ATRIAL AND VENTRICULAR RATE HISTOGRAM DATA WAS MISSING/INVALID. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INFORMATION WAS RECEIVED FROM A CONSUMER AND A HEALTHCARE PROFESSIONAL VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (20 MG/ML AT 7 MG/DAY) VIA AN IMPLANTED PUMP. ON (B)(6) 2020 IT WAS REPORTED THAT THE PATIENT WAS IN THE ER (EMERGENCY ROOM) BECAUSE SHE NOTICED THAT HER PUMP WAS ALARMING, AND SHE STARTED TO NOTICE WITHDRAWAL SYMPTOMS. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. PUMP ERI (ELECTIVE REPLACEMENT INDICATOR) WAS (B)(6) OF 2020. THE PUMP WAS INTERROGATED AND FOUND TO BE STALLED. THE PATIENT HAD NOT HAD ANY RECENT MRI IMAGING. THE PUMP WAS PROGRAMMED TO MINIMUM RATE AND THE PATIENT WAS GOING TO CONSULT WITH THE MANAGING PHYSICIAN¿S OFFICE TO BE SCHEDULED FOR PUMP REPLACEMENT. NO SURGICAL INTERVENTION OCCURRED, AND NONE WAS PLANNED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT, AND IT WAS INDICATED THAT THE HCP HAD NO FURTHER INFORMATION TO PROVIDE REGARDING THE EVENT. THE PATIENT STATUS WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING SHORT VENTRICLE-VENTRICLE (V-V) INTERVALS, FLUCTUATING R W AVE, UNDER-SENSING AND AN INCREASE IN THRESHOLDS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PACING LEAD DISLODGED REPEATEDLY DURING THE IMPLANT PROCEDURE. THE PACING LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION APPROXIMATELY THREE WEEKS POST IMPLANT. A REPLACEMENT PROCEDURE IS PLANNED IN THE FUTURE AND WILL BE ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | EVERA MRI XT DR SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS FURTHER REPORTED THAT AN INTERROGATION OF THE DEVICE AT CLINIC SHOWED THAT DEVICE MEASUREMENTS WERE WITHIN NORMAL LIMITS. A CARDIAC MAGNETIC RESONANCE IMAGING (MRI) WAS PLANNED. NO OTHER ACTION WAS TAKEN AND THE DEVICE REMAINS IN USE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ALLOWING THEM TO SLEEP. THE PATIENT WAS EXPERIENCING A HEADACHE, POUNDING OF THE HEART AND REPORTEDLY HAD HIGH BLOOD PRESSURE AND A BLACKOUT. THE POUNDING OF THE HEART THAT THE PATIENT WAS EXPERIENCING USED TO BE CAUSED BY A THYROID ISSUE BUT THE PATIENT WAS TOLD BY THEIR PHYSICIAN THAT THEIR THYROID WAS NOW FINE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | CAPSUREFIX NOVUS LEAD MRI SURESCAN | ELECTRODE, PACEMAKER, PERMANENT | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A BREAK, HIGH UNDEFINED IMPEDANCE AND NOISE. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | THERE IS NO ALLEGATION AGAINST THE PERFORMANCE OF THIS PRODUCT. THE PRODUCT IS BEING EVALUATION IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS REPORT WILL BE UPDATED WHEN EVALUATION IS COMPLETE. IT WAS REPORTED THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE ONE DAY POST IMPLANT DUE TO A PERFORATION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A TEMPORARY PACING LEAD WAS PLACED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A REVISION PROCEDURE WAS PERFORMED AND THE ENTIRE SYSTEM WAS REMOVED FROM SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | IMPLANTABLE LEAD | (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE REPRESENTATIVE. THIS INVESTIGATION WILL BE UPDATED SHOULD PERTINENT INFORMATION BE PROVIDED. IT WAS REPORTED THAT THIS LEAD WAS REVISED DUE TO UNKNOWN ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE EXHIBITED OVERSENSING OF NOISE GENERATED BY THE MINUTE VENTILATION (MV)/RESPIRATORY SENSOR THAT IS RELATED TO A HIGH IMPEDANCE CONDITION. PLEASE SEE THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. THIS DEVICE WAS INCLUDED IN THE RECENT MINUTE VENTILATION SENSOR SIGNAL OVERSENSING ADVISORY POPULATION. IT WAS REPORTED THAT THIS PACEMAKER HAD A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE DUE TO OVERSENSING OF THE MINUTE VENTILATION SENSOR. TROUBLESHOOTING INCLUDED TURNING OFF THE MINUTE VENTILATION FEATURE AS IT WAS NOT BEING USED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | IMPLANTABLE LEAD | UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS EXTENDED AND DRIED BLOOD/TISSUE WAS PRESENT AROUND THE HELIX. RESISTANCE TESTING FOUND THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS CONFIRMED THAT THE INNER CONDUCTOR COIL HAD A BREAK AT THE DISTAL END OF THE TERMINAL PIN. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THAT TORSIONAL OVERSTRESS DURING ATTEMPTS TO EXTEND/RETRACT THE HELIX CAUSED THE INNER CONDUCTOR COIL TO BREAK. THE DISLODGEMENT AND PERICARDIAL EFFUSION ALLEGATIONS WERE NOT CONFIRMED, LAB OBSERVATIONS AND FIELD REPORT WERE INSUFFICIENT TO VERIFY ALLEGATIONS. IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HELIX FAILED TO RETRACT WHEN REPOSITIONED DUE TO A DISLODGEMENT. THE PHYSICIAN NOTED A SMALL PERICARDIAL EFFUSION. IT WAS CONFIRMED THROUGHOUT AN ECHOGRAPHY PERFORMED IN THE LAST HALF OF THE PROCEDURE. THIS LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RETURNED. IF FURTHER PERTINENT INFORMATION IS RECEIVED FROM PRODUCT INVESTIGATION THIS REPORT WOULD BE UPDATED AT THAT TIME. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHEN POSITIONING THIS RIGHT VENTRICULAR (RV) LEAD AND IT NEEDED TO BE REPOSITIONED. AFTER THE SECOND PLACEMENT ATTEMPT, IT WAS NOTED THAT THE HELIX WAS ONLY PARTIALLY EXTENDED, AND THE RV LEAD BECAME DISLODGED. AFTERWARDS, THE HELIX COULD NOT BE FULLY RETRACTED AND THIS LEAD WAS REMOVED AND REPLACED. AN ECHOCARDIOGRAPHY WAS PERFORMED AND A SMALL PERICARDIAL EFFUSION WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | INGEVITY MRI | IMPLANTABLE LEAD | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS WONDERING IF HE PULLED HIS RIGHT ATRIAL (RA) LEAD ALONG WITH THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | ACCOLADE MRI DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE COMPLETED EVALUATION OF THIS PRODUCT. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THERE IS NO ALLEGATION AGAINST THE PERFORMANCE OF THIS PRODUCT. THE PRODUCT IS BEING EVALUATION IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS REPORT WILL BE UPDATED WHEN EVALUATION IS COMPLETE. IT WAS REPORTED THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE ONE DAY POST IMPLANT DUE TO A PERFORATION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A TEMPORARY PACING LEAD WAS PLACED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A REVISION PROCEDURE WAS PERFORMED AND THE ENTIRE SYSTEM WAS REMOVED FROM SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | IMPLANTABLE LEAD | IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND HIGH PACING THRESHOLD, IT ALSO EXHIBITED LOSS OF CAPTURE AND SENSING ISSUES A SURGICAL INTERVENTION WAS NECESSARY TO RESOLVE THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. PATIENT CODE (B)(4) CAPTURES THE REPORTABLE EVENT OF SURGERY. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. (B)(4). IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS, NO SENSING AND LOSS OF CAPTURE. FURTHER EXAMINATION SHOWED THE LEAD HAD BECOME DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS EXPLANTED, REPLACED, AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Injury | INGEVITY MRI | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | THIS PRODUCT IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS REPORT WILL BE UPDATED WHEN EVALUATION IS COMPLETE. IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) EXHIBITED LOSS OF CAPTURE ONE DAY POST IMPLANT DUE TO PERFORATION WHICH WAS CONFIRMED VIA ECHOCARDIOGRAM. A TEMPORARY PACING LEAD WAS PLACED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A REVISION PROCEDURE WAS PERFORMED AND THE ENTIRE SYSTEM WAS REMOVED FROM SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY WITH THE HELIX MECHANISM WAS IN THE RETRACTED POSITION. VISUAL INSPECTION FOUND DRIED BLOOD AROUND THE HELIX. SUBSEQUENT TESTING DID NOT IDENTIFY ANY PRODUCT ABNORMALITIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE COMPLETED EVALUATION OF THIS PRODUCT. |
20,200,427 | Malfunction | INGEVITY MRI | IMPLANTABLE LEAD | AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS WONDERING IF HE PULLED HIS RIGHT VENTRICULAR (RV) LEAD ALONG WITH THE RIGHT ATRIAL (RA) LEAD. BOTH LEADS REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE S MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASED SENSING INTEGRITY COUNTER (SIC), AND MULTIPLE NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS DUE TO NOISE. THE LEAD ALSO EXHIBITED VARYING PACING IMPEDANCES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SENSING INTEGRITY COUNTER. ANALYSIS OF THE DEVICE MEMORY INDICATED THE CRITERIA FOR THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT WERE MET. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND OF THE RIGHT VENTRICULAR PACING LEAD WAS VARIABLE. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO ELECTROMAGNETIC INTERFERENCE/NOISE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION WAS RECEIVED ON 30-APR-2020 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT THE ON (B)(6) 2020 THE NURSE PROGRAMMED THE PATIENT¿S PUMP TO MINIMUM RATE AND SILENCED THE MOTOR STALL ALARM AT THAT TIME. THE PATIENT REPORTED THAT THE PUMP STARTED ALARMING AGAIN AND THEY WERE WONDERING WHY. IT WAS REVIEWED THAT IF THE PUMP WAS GOING THROUGH MULTIPLE MOTOR STALLS AND RECOVERIES THAT THE PUMP COULD START TO ALARM AGAIN SINCE ONLY AN ACTIVE ALARM CAN BE SILENCED. THE REPORTER WAS PLANNING TO RELAY THIS INFORMATION TO THE HCP. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY EMI (ELECTROMAGNETIC INTERFERENCE) OR MAGNETIC EXPOSURE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY AND MANUFACTURER REPRESENTATIVE (REP) REPORTED THE CLINICAL DIAGNOSIS WAS UPDATED TO INCREASED PAIN. IT WAS NOTED THE PUMP WAS BEING SENT BACK FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REPORTED THE PATIENT HAD FLU-LIKE SYMPTOMS OF NAUSEA, DIAPHORESIS, AND SHAKINESS STARTING ON 2020-(B)(6) WITH INCREASED PAIN. IT WAS NOTED ON 2020-(B)(6) THE PATIENT REPORTED THERE WAS A CRITICAL ALARM ON 2020--(B)(6) AND ON 2020--(B)(6) . DEVICE INTERROGATION ON 2020--(B)(6) REVEALED A PUMP STALL ON 2020--(B)(6) AND PUMP STOPPED ON 2020--(B)(6) . ON 2020--(B)(6) A FENTANYL PATCH (25 MCG) WAS PRESCRIBED UNTIL SURGERY. THE PUMP WAS EXPLANTED/REPLACED ON 2020--(B)(6) . THE OUTCOME OF THE EVENT RESOLVED WITHOUT SEQUELAE ON 2020--(B)(6) . THE DEVICE DISPOSITION WAS RETURNED TO MANUFACTURER. THE ETIOLOGY OF THE EVENT INDICATED THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR THERAPY WAS RELATED AND INDICATED THE RELATIONSHIP OF THE EVENT TO THE IMPLANT PROCEDURE WAS NOT RELATED. NO FURTHER COMPLICATIONS WERE REPORTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REPORTED THE SYMPTOMS WERE MOST LIKELY WITHDRAWAL SYMPTOMS. IT WAS UNKNOWN WHY A MOTOR STALL OCCURRED. IT WAS NOTED THE PATIENT DID NOT HAVE A MAGNETIC RESONANCE IMAGING. NO FURTHER COMPLICATIONS WERE REPORTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY REPORTED THE CLINICAL DIAGNOSIS WAS UPDATED TO PAIN AND MEDICATION WITHDRAWAL. NO FURTHER COMPLICATIONS WERE REPORTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND MANUFACTURE REPRESENTATIVE REGARDING A PATIENT RECEIVING FENTANYL (500 MCG/ML AT 273.7 MCG/DAY) VIA AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THE HCP SAW THE PATIENT YESTERDAY WHEN THEY REPORTED AN ALARM HEARD FROM THE PUMP. THE LOGS REVEALED A MOTOR STALL ON (B)(6) 2020. IT WAS NOTED THE PUMP HAD BEEN STALLED FOR 104 HOURS AND TUBE SET OCCURRED. IT WAS NOTED THE PATIENT DID NOT HAVE AN MRI RECENTLY. THE CALLER STATED THE PATIENT REPORTED FEELING SYMPTOMS OF UNDERDOSE BUT THOUGHT THEY MIGHT HAVE A COLD/FLU SO WAS CONFUSED AND DIDN'T RECOGNIZE SYMPTOMS WERE LIKELY RELATED TO THE PUMP ALARMING. THE PATIENT HAD SYMPTOMS OF UNDERDOSE IN THE FIRST 24-48 HOURS AND NOW THE PATIENT HAD A RETURN OF PAIN. IT WAS REVIEWED HOW TO SILENCE THE PUMP ALARM. THE HCP WAS GOING TO THE PATIENT'S HOUSE TO SILENCE THE ALARM. THE NEXT STEPS WERE NOT KNOWN YET. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2020 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT THE PUMP HAD NOT BEEN INTERROGATED SINCE IT HAD STARTED ALARMING AGAIN AFTER THE ALARM WAS SILENCED ON 25-APR-2020. NO ACTION WAS TAKEN REGARDING THE CURRENT ALARM. THE PATIENT WAS BEING SCHEDULED FOR A PUMP REPLACEMENT. THE DATE WAS UNKNOWN AT THE TIME OF THIS REPORT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. UPDATED TO REFLECT THE INFORMATION RECEIVED ON 2020-APR-27: INITIAL REPORTER INFORMATION UPDATED TO REFLECT INFORMATION RECEIVED ON 2020-APR-27. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER'S REPRESENTATIVE (REP) ON 2020-APR-27. IT WAS CONFIRMED THAT THE HCP INITIALLY REPORTED THE MOTOR STALL TO THE MANUFACTURER'S REPRESENTATIVE. THE CAUSE OF THE MOTOR STALL WAS NOT DETERMINED. THE PATIENT'S PUMP WAS TURNED TO MINIMUM RATE AND THE PATIENT WAS PRESCRIBED ORAL MEDICATION. HOWEVER, THE MOTOR STALL HAD NOT BEEN RESOLVED. THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED PRODUCT ANALYSIS #255486991:ANALYSIS INFORMATION -- 2020-08-07 09:54:23 CST PLI# 10, PRODUCT ID# 8637-40. THE PUMP WAS RETURNED, AND ANALYSIS FOUND CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE MRI SURESCAN | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Injury | SPRINT QUATTRO SECURE MRI SURESCAN | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT ALERT TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN JUMP IN IMPEDANCES, AN INCREASED SENSING INTEGRITY COUNTER (SIC), AND A POSSIBLE FRACTURE. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
20,200,427 | Malfunction | AESTIVA MRI | ANESTHESIA GAS MACHINE | A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE SENSOR INTERFACE BOARD (SIB) WAS REPLACED TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE HOSPITAL REPORTED AN ERROR RESULTING IN THE LOSS OF MECHANICAL VENTILATION. THERE WAS NO REPORT OF PATIENT INJURY. |
20,200,427 | Malfunction | SPRINT QUATTRO SECURE MRI SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNDEFINED SVC (SUPERIOR VENA CAVA) COIL IMPEDANCE. IT WAS NOTED THAT THERE WAS VARIED IMPEDANCE ON THE RV COIL WITH THE SVC COIL ACTIVATED AND A "INTERMITTENT FRACTURE OF THE SVC." THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
20,200,427 | Injury | CLARIA MRI QUAD CRT-D SURESCAN | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | CONCOMITANT MEDICAL PRODUCTS: 694765, LEAD, IMPLANTED: (B)(6) 2009. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS FAST VENTRICULAR TACHYCARDIA (VT). FOLLOW UP YIELDED NO INFORMATION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. |
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