ADVANTIO
Report
- Report Number
- 2124215-2025-37747
- Event Type
- Injury
- Date Received
- June 9, 2025
- Date of Event
- May 31, 2025
- Report Date
- September 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- N970003/S132
- Removal / Correction Number
- Z-2016-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.
THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE UDI REGULATION AND AS A RESULT, THE COMPLETE UDI IS NOT AVAILABLE. APPLICABLE US PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE DETERMINED IT HAD UNDERGONE RESETS AND THAT BRADYCARDIA THERAPY REMAINED AVAILABLE. ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH INTERNAL CELL IMPEDANCE WITHIN THE BATTERY. THE HIGH INTERNAL IMPEDANCE RESULTED IN THE SYSTEM RESETS DUE TO TEMPORARY HIGH-POWER CONSUMPTION (DURING TELEMETRY OR OTHER HIGHER POWER DEVICE OPERATIONS) AND SUBSEQUENT REVERSION TO SAFETY MODE OPERATION. BOSTON SCIENTIFIC HAS ISSUED A FIELD SAFETY NOTICE REGARDING INGENIO EXTENDED LIFE (EL) AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICES THAT MAY EXHIBIT THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE HIGH IMPEDANCE IN INGENIO EXTENDED LIFE (EL) PACEMAKER AND CRT-P ADVISORY POPULATION.
IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE, WHICH PERMANENTLY LIMITS DEVICE FUNCTION. THIS PACEMAKER IS STILL IN SERVICE. TECHNICAL SERVICES (TS) RECOMMENDED THIS PACEMAKER BE REPLACED SOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED. THIS DEVICE IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE, WHICH PERMANENTLY LIMITS DEVICE FUNCTION. THIS PACEMAKER IS STILL IN SERVICE. TECHNICAL SERVICES (TS) RECOMMENDED THIS PACEMAKER BE REPLACED SOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE, WHICH PERMANENTLY LIMITS DEVICE FUNCTION. THIS PACEMAKER IS STILL IN SERVICE. TECHNICAL SERVICES (TS) RECOMMENDED THIS PACEMAKER BE REPLACED SOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED. THIS DEVICE IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIVING ADDITIONAL INFORMATION, THIS PACEMAKER WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION (PBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER ENTERED SAFETY MODE, WHICH PERMANENTLY LIMITS DEVICE FUNCTION. THIS PACEMAKER IS STILL IN SERVICE. TECHNICAL SERVICES (TS) RECOMMENDED THIS PACEMAKER BE REPLACED SOON. NO ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED. THIS DEVICE IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. UPON RECEIVING ADDITIONAL INFORMATION, THIS PACEMAKER WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION (PBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1344649 | ADVANTIO | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | K064 | 111812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Male | Required Intervention| H |