INGEVITY?+
Report
- Report Number
- 2124215-2025-19459
- Event Type
- Injury
- Date Received
- March 28, 2025
- Date of Event
- March 3, 2025
- Report Date
- June 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604522
- PMA / PMN Number
- P150012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
REVISION TO THE INITIAL MDR IN BLOCK H6 IMPACT CODE.
REVISION TO THE INITIAL MDR IN BLOCK H6 IMPACT CODE.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING FAILURE AND HIGH PACING THRESHOLD. A CHEST X-RAY WAS PERFORMED AND SHOWED THE LEAD WAS PULLED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING FAILURE AND HIGH PACING THRESHOLD. A CHEST X-RAY WAS PERFORMED AND SHOWED THE LEAD WAS PULLED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING FAILURE AND HIGH PACING THRESHOLD. A CHEST X-RAY WAS PERFORMED AND SHOWED THE LEAD WAS PULLED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS LEAD WAS SURGICALLY EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711960 | INGEVITY?+ | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7842 | 1336872 | 00802526604522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Female | Required Intervention| H |