INGENIO?
Report
- Report Number
- 2124215-2025-69728
- Event Type
- Injury
- Date Received
- October 2, 2025
- Date of Event
- September 25, 2025
- Report Date
- April 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526536786
- PMA / PMN Number
- N970003
- Removal / Correction Number
- Z-2016-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GFE WAS SENT TO REQUEST INFORMATION REGARDING THE DEVICE EXPLANT STATUS, PATIENT OUTCOME, AND DEVICE RETURN, AS WELL AS DETAILS ABOUT THE INITIAL REPORTER, IF A RESPONSE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE UPLOADED. GFE RESPONSE INDICATED THE DEVICE WAS EXPLANTED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS.
A GFE WAS SENT TO REQUEST INFORMATION REGARDING THE DEVICE EXPLANT STATUS, PATIENT OUTCOME, AND DEVICE RETURN, AS WELL AS DETAILS ABOUT THE INITIAL REPORTER, IF A RESPONSE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE UPLOADED. GFE RESPONSE INDICATED THE DEVICE WAS EXPLANTED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS. SINCE THE EXPLANT DATE WAS NOT PROVIDED, AN APPROXIMATE DATE HAS BEEN ASSIGNED. ADDITIONAL INFORMATION RECEIVED INDICATED THE EXPLANT DATE.
A GFE WAS SENT TO REQUEST INFORMATION REGARDING THE DEVICE EXPLANT STATUS, PATIENT OUTCOME, AND DEVICE RETURN, AS WELL AS DETAILS ABOUT THE INITIAL REPORTER, IF A RESPONSE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE UPLOADED. GFE RESPONSE INDICATED THE DEVICE WAS EXPLANTED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS. SINCE THE EXPLANT DATE WAS NOT PROVIDED, AN APPROXIMATE DATE HAS BEEN ASSIGNED. ADDITIONAL INFORMATION RECEIVED INDICATED THE EXPLANT DATE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE CONFIRMED IT WAS OPERATING IN SAFETY MODE 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF DEVICE DISPLAYS ERROR MESSAGE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO DEVICE DESIGN.
A GFE WAS SENT TO REQUEST INFORMATION REGARDING THE DEVICE EXPLANT STATUS, PATIENT OUTCOME, AND DEVICE RETURN, AS WELL AS DETAILS ABOUT THE INITIAL REPORTER, IF A RESPONSE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE UPLOADED. GFE RESPONSE INDICATED THE DEVICE WAS EXPLANTED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS. SINCE THE EXPLANT DATE WAS NOT PROVIDED, AN APPROXIMATE DATE HAS BEEN ASSIGNED.
A GFE WAS SENT TO REQUEST INFORMATION REGARDING THE DEVICE EXPLANT STATUS, PATIENT OUTCOME, AND DEVICE RETURN, AS WELL AS DETAILS ABOUT THE INITIAL REPORTER, IF A RESPONSE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE UPLOADED.
IT WAS REPORTED THAT THIS PACEMAKER HAD BEEN SWITCHED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM GFE RESPONSE INDICATED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER HAD BEEN SWITCHED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM GFE RESPONSE INDICATED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER HAD BEEN SWITCHED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM GOOD FAITH EFFORT (GFE) RESPONSE INDICATED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS PRODUCT HAS BEEN RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER HAD BEEN SWITCHED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM GFE RESPONSE INDICATED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED; HOWEVER, NO FURTHER INFORMATION WAS OBTAINED REGARDING THE DATE OR ADDITIONAL DETAILS. THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS PACEMAKER HAD BEEN SWITCHED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529035 | INGENIO? | IMPLANTABLE PACEMAKER | LWP | BOSTON SCIENTIFIC CORPORATION | K174 | 114257 | 00802526536786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Required Intervention| H |