ACCOLADE DR
Report
- Report Number
- 2124215-2025-29965
- Event Type
- Injury
- Date Received
- May 9, 2025
- Date of Event
- April 22, 2025
- Report Date
- February 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526559174
- PMA / PMN Number
- N970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING EVENT RESOLUTION AND INITIAL REPORTER DETAILS. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. CORRECTION TO B5: UPDATED FOR CLARITY. CORRECTION TO H6: DEVICE CODE A160503 / INAPPROPRIATE OR UNEXPECTED RESET AND PATIENT CODE E020204 / MALAISE ADDED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE CASE WAS OPENED, AND THE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. THE CURRENT DRAIN OF THE HYBRID CIRCUIT WAS MEASURED AND FOUND TO BE NORMAL. THE BATTERY WAS FORWARDED FOR DETAILED TESTING. THIS TESTING CONFIRMED THE BATTERY WAS DEPLETED; HOWEVER, DESPITE ANALYSIS, THE ROOT CAUSE OF THE BATTERY DEPLETION AND REVERSION TO SAFETY MODE COULD NOT BE DETERMINED. BASED ON AVAILABLE EVIDENCE, IT IS LIKELY THAT THIS DEVICE EXHIBITED THE BEHAVIOR DESCRIBED IN THE HIGH BATTERY IMPEDANCE FIELD SAFETY COMMUNICATION ISSUED TO PHYSICIANS IN DECEMBER 2024 WITH AN EXPANSION IN 2025. HOWEVER, ROOT CAUSE CANNOT BE CONFIRMED IN THIS CASE BECAUSE THE RETURNED BATTERY HAS INSUFFICIENT POWER REMAINING TO MAINTAIN DEVICE DIAGNOSTIC DATA, AND THE BATTERY VOLTAGE IS TOO LOW TO PROVIDE EVIDENCE OF HIGH BATTERY IMPEDANCE THROUGH DIRECT TESTING OF THE BATTERY.
THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING EVENT RESOLUTION AND INITIAL REPORTER DETAILS. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED. CORRECTION TO B5: UPDATED FOR CLARITY. CORRECTION TO H6: DEVICE CODE A160503/ INAPPROPRIATE OR UNEXPECTED RESET AND PATIENT CODE E020204/MALAISE ADDED.
IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT AS A PRIORITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE DEVICE REMAINS IN SERVICE FOR THE TIME BEING.
IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) BECAUSE SHE FELT UNWELL. IT WAS CONFIRMED THAT THE PACEMAKER WAS OPERATING IN SAFETY MODE AND HAD RECORDED CODES 0X40 0X0 0X0 0X0. CODE 0X40 WAS INDICATIVE OF THREE POWER ON RESETS (PORS). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION RECEIVED FOUR MONTHS LATER REPORTED THAT THIS PACEMAKER WAS RECEIVED FOR RETURN ANALYSIS, WHICH INDICATES THE PRODUCT WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) BECAUSE SHE FELT UNWELL. IT WAS CONFIRMED THAT THE PACEMAKER WAS OPERATING IN SAFETY MODE AND HAD RECORDED CODES 0X40 0X0 0X0 0X0. CODE 0X40 WAS INDICATIVE OF THREE POWER ON RESETS (PORS). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION RECEIVED FOUR MONTHS LATER REPORTED THAT THIS PACEMAKER WAS RECEIVED FOR RETURN ANALYSIS, WHICH INDICATES THE PRODUCT WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021980 | ACCOLADE DR | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | L301 | 751758 | 00802526559174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention| H |