ACCOLADE EL DR
Report
- Report Number
- 2124215-2021-32250
- Event Type
- Injury
- Date Received
- January 1, 2022
- Date of Event
- October 12, 2021
- Report Date
- December 28, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526559242
- PMA / PMN Number
- N970003/S167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE H6 FIELDS HAVE BEEN UPDATED BASED ON NEW INFORMATION RECEIVED. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
THE H6 FIELDS HAVE BEEN UPDATED BASED ON NEW INFORMATION RECEIVED. SHOULD FURTHER INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. 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 ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF DEVICES IN THE ACCOLADE PACEMAKER FAMILY THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE HYDROGEN INDUCED PREMATURE DEPLETION ADVISORY POPULATION.
IT WAS REPORTED THAT THERE WERE CONCERNS OF PREMATURE BATTERY DEPLETION (PBD) FOR THIS PACEMAKER AS THE BATTERY LONGEVITY PROJECTION HAD DEPLETED MORE THAN EXPECTED SINCE THE LAST CHECKUP. BASED ON THE AVAILABLE DATA BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ESTIMATED A SAFE REPLACEMENT INTERVAL OF 90 DAYS AND DISCUSSED OPTIONS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION WAS RECEIVED APPROXIMATELY TWO MONTHS AFTER THE INITIAL REPORT AND DATA ANALYSIS BY TS CONFIRMED THAT THE BATTERY CONSUMPTION HAD BEEN INCREASING. DEVICE REPLACEMENT WAS RECOMMENDED WITHIN 90 DAYS.
IT WAS REPORTED THAT THERE WERE CONCERNS OF PREMATURE BATTERY DEPLETION (PBD) FOR THIS PACEMAKER AS THE BATTERY LONGEVITY PROJECTION HAD DEPLETED MORE THAN EXPECTED SINCE THE LAST CHECKUP. BASED ON THE AVAILABLE DATA BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ESTIMATED A SAFE REPLACEMENT INTERVAL OF 90 DAYS AND DISCUSSED OPTIONS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION WAS RECEIVED APPROXIMATELY TWO MONTHS AFTER THE INITIAL REPORT AND DATA ANALYSIS BY TS CONFIRMED THAT THE BATTERY CONSUMPTION HAD BEEN INCREASING. DEVICE REPLACEMENT WAS RECOMMENDED WITHIN 90 DAYS.
IT WAS REPORTED THAT THERE WERE CONCERNS OF PREMATURE BATTERY DEPLETION (PBD) FOR THIS PACEMAKER AS THE BATTERY LONGEVITY PROJECTION HAD DEPLETED MORE THAN EXPECTED SINCE THE LAST CHECKUP. BASED ON THE AVAILABLE DATA BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ESTIMATED A SAFE REPLACEMENT INTERVAL OF 90 DAYS AND DISCUSSED OPTIONS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION WAS RECEIVED APPROXIMATELY TWO MONTHS AFTER THE INITIAL REPORT AND DATA ANALYSIS BY TS CONFIRMED THAT THE BATTERY CONSUMPTION HAD BEEN INCREASING. DEVICE REPLACEMENT WAS RECOMMENDED WITHIN 90 DAYS. FURTHER INFORMATION WAS RECEIVED THAT THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED.
IT WAS REPORTED THAT THERE WERE CONCERNS OF PREMATURE BATTERY DEPLETION (PBD) FOR THIS PACEMAKER AS THE BATTERY LONGEVITY PROJECTION HAD DEPLETED MORE THAN EXPECTED SINCE THE LAST CHECKUP. BASED ON THE AVAILABLE DATA BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ESTIMATED A SAFE REPLACEMENT INTERVAL OF 90 DAYS AND DISCUSSED OPTIONS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. INFORMATION WAS RECEIVED APPROXIMATELY TWO MONTHS AFTER THE INITIAL REPORT AND DATA ANALYSIS BY TS CONFIRMED THAT THE BATTERY CONSUMPTION HAD BEEN INCREASING. DEVICE REPLACEMENT WAS RECOMMENDED WITHIN 90 DAYS. FURTHER INFORMATION WAS RECEIVED THAT THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436204 | ACCOLADE EL DR | PACEMAKER | LWP | BOSTON SCIENTIFIC CORPORATION | L321 | 707153 | 00802526559242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention| H |