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 |
|---|---|---|---|---|
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... |
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 HIG... |
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 INFORMA... |
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 I... |
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 ... |
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 PECTORA... |
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 PROVI... |
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 IMP... |
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 ... |
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 GENERATO... |
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 RESU... |
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 SUPPLEMENT... |
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 ... |
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 ... |
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 ... |
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 SUM... |
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 ... |
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 A... |
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 EXHI... |
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 ... |
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 S... |
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 ... |
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 ... |
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... |
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 RESUL... |
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 EXPE... |
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 TH... |
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... |
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... |
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 VENTRICULA... |
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... |
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... |
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 H... |
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. ... |
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 ... |
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... |
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 VENTRICULA... |
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 FAILUR... |
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... |
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 30... |
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 A... |
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... |
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 WE... |
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 INAPPROP... |
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... |
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 ... |
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 M... |
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 DETE... |
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 REPORTE... |
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 A... |
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 OVERSEN... |
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) RECOMMEN... |
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 ASSE... |
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 WA... |
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 C... |
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 DETE... |
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 R... |
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... |
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 COMPLICATION... |
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. TH... |
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 OBTAINE... |
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... |
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 INFORMA... |
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 COMPLIC... |
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 CARDI... |
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 R... |
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 DEFIBRILLATO... |
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 U... |
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 ... |
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... |
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 R... |
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... |
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 ... |
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... |
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 ... |
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. B... |
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 PROP... |
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... |
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... |
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. B... |
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... |
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 A... |
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... |
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 ... |
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 ... |
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 VE... |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.