FDA Adverse Event
Injury
Summary report: N
INGEVITY+
MDR report key: 22945971
·
Received September 2, 2025
Report
- Report Number
- 2124215-2025-61604
- Event Type
- Injury
- Date Received
- September 2, 2025
- Date of Event
- March 13, 2024
- Report Date
- September 10, 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
- PR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUBMITTED TO CORRECT THE BSC AWARE DATE FIELD (G3) IN SECTION G.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ONLY IMPLANTED FOR TWO DAYS DUE TO LEAD PERFORATION AND PATIENT EXPERIENCED PAIN. THIS RV LEAD WAS REPLACED WITH A DIFFERENT MODEL AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ONLY IMPLANTED FOR TWO DAYS DUE TO LEAD PERFORATION AND PATIENT EXPERIENCED PAIN. THIS RV LEAD WAS REPLACED WITH DIFFERENT MODEL AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1851632 | INGEVITY+ | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7842 | 1288203 | 00802526604522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Life Threatening| H| R |