CONTAK RENEWAL 3 HE
Report
- Report Number
- 2124215-2010-17807
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- September 6, 2010
- Report Date
- October 15, 2019
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIK
- PMA / PMN Number
- P010012/S008
- Removal / Correction Number
- Z-0949-05 THRU Z-0953-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PATIENT'S EJECTION FRACTION HAD IMPROVED TO APPROXIMATELY 50% AND THE PATIENT AND PHYSICIAN WERE STILL DISCUSSING FUTURE OPTIONS. THE DEVICE REMAINS IMPLANTED.
NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.
THE EXPLANTED DEVICE WAS RECEIVED AND IS UNDERGOING LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED THE CASE WAS SWOLLEN; THE LV+ SEAL PLUG WAS DAMAGED AND THE RV+ SEAL PLUG WAS MISSING. THE SETSCREWS MOVED FREELY. THE DEVICE HAD NO TELEMETRY. THE DEVICE CASE WAS REMOVED AND AN EXTERNAL POWER SOURCE WAS ATTACHED FOR ADDITIONAL TESTING. MANUAL ELECTRICAL MEASUREMENTS NOTED NORMAL SENSING, PACING, AND DEFIBRILLATION FUNCTIONS. IT WAS NOTED THE ESTIMATED LONGEVITY FOR THIS MODEL DEVICE WAS 4.7 TO 5.0 YEARS, PER LABELING. THE DEVICE HAD BEEN IMPLANTED FOR 5.83 YEARS WHEN END OF LIFE (EOL) BATTERY STATUS WAS DECLARED EARLIER THAN EXPECTED (ONE MONTH AFTER ERI). HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSED ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.
THE EXPLANTED DEVICE WAS RECEIVED AND IS UNDERGOING LABORATORY ANALYSIS. TIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DECLARED END OF LIFE (EOL) BATTERY STATUS EARLIER THAN EXPECTED, WITH A MONITORING VOLTAGE OF 2.57V AND A CHARGE TIME OF 33.3 SECONDS. A RED ALERT WAS ISSUED IN LATITUDE FOR THIS BATTERY STATUS CHANGE. IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS HAD BEEN DECLARED THE PREVIOUS MONTH. TECHNICAL SERVICES DISCUSSED WITH THE PHYSICIAN THAT ALL BRADY PACING AND MAXIMUM ENERGY SHOCKS REMAINED AVAILABLE AT EOL. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND APPEARED TO BE EXHIBITING THE ADVISORY BEHAVIOR.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DECLARED END OF LIFE (EOL) BATTERY STATUS EARLIER THAN EXPECTED, WITH A MONITORING VOLTAGE OF 2.57V AND A CHARGE TIME OF 33.3 SECONDS. A RED ALERT WAS ISSUED IN LATITUDE FOR THIS BATTERY STATUS CHANGE. IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS HAD BEEN DECLARED THE PREVIOUS MONTH. TECHNICAL SERVICES DISCUSSED WITH THE PHYSICIAN THAT ALL BRADY PACING AND MAXIMUM ENERGY SHOCKS REMAINED AVAILABLE AT EOL. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND APPEARED TO BE EXHIBITING THE ADVISORY BEHAVIOR. THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PATIENT'S EJECTION FRACTION HAD IMPROVED TO APPROXIMATELY 50% AND THE PATIENT AND PHYSICIAN WERE STILL DISCUSSING FUTURE OPTIONS. THE DEVICE REMAINS IMPLANTED. NINE YEARS LATER, THIS DEVICE WAS EXPLANTED AND REPLACED. THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED FOR AN UNKNOWN PRODUCT PERFORMANCE ISSUE. THE PATIENT RECEIVED A NEW LEAD SYSTEM WITH THE NEW DEVICE (THERE WAS NOT PREVIOUSLY AN RA OR LV LEAD IMPLANTED). THERE WERE NO FURTHER ALLEGATIONS AGAINST THE DEVICE; IT IS SUSPECTED THE SYSTEM WAS ABANDONED ELECTRICALLY WHEN THE PATIENT'S CONDITION WAS IMPROVED IN 2010. LIKELY, THE PATIENT'S CONDITION DECLINED IN 2019, REQUIRING A NEW CRT-D. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DECLARED END OF LIFE (EOL) BATTERY STATUS EARLIER THAN EXPECTED, WITH A MONITORING VOLTAGE OF 2.57V AND A CHARGE TIME OF 33.3 SECONDS. A RED ALERT WAS ISSUED IN LATITUDE FOR THIS BATTERY STATUS CHANGE. IT WAS NOTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS HAD BEEN DECLARED THE PREVIOUS MONTH. TECHNICAL SERVICES DISCUSSED WITH THE PHYSICIAN THAT ALL BRADY PACING AND MAXIMUM ENERGY SHOCKS REMAINED AVAILABLE AT EOL. THE DEVICE WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY AND APPEARED TO BE EXHIBITING THE ADVISORY BEHAVIOR. THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PATIENT'S EJECTION FRACTION HAD IMPROVED TO APPROXIMATELY 50% AND THE PATIENT AND PHYSICIAN WERE STILL DISCUSSING FUTURE OPTIONS. THE DEVICE REMAINS IMPLANTED. NINE YEARS LATER, THIS DEVICE WAS EXPLANTED AND REPLACED. THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED FOR AN UNKNOWN PRODUCT PERFORMANCE ISSUE. THE PATIENT RECEIVED A NEW LEAD SYSTEM WITH THE NEW DEVICE (THERE WAS NOT PREVIOUSLY AN RA OR LV LEAD IMPLANTED). THERE WERE NO FURTHER ALLEGATIONS AGAINST THE DEVICE; IT IS SUSPECTED THE SYSTEM WAS ABANDONED ELECTRICALLY WHEN THE PATIENT'S CONDITION WAS IMPROVED IN 2010. LIKELY, THE PATIENT'S CONDITION DECLINED IN 2019, REQUIRING A NEW CRT-D. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 3 HE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D | NIK | BOSTON SCIENTIFIC CORPORATION | H177 | 502219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | 6949| H177 |