FDA Adverse Event
Malfunction
Summary report: N
INGEVITY? MRI
MDR report key: 22713710
·
Received August 5, 2025
Report
- Report Number
- 2124215-2025-54284
- Event Type
- Malfunction
- Date Received
- August 5, 2025
- Date of Event
- July 17, 2025
- Report Date
- August 5, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526523335
- PMA / PMN Number
- P150012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING HIGH-RATE EVENTS. TECHNICAL SERVICES (TS) REVIEWED EPISODES NOTING SEVERAL EVENTS WITH UNDERSENSING AND RV WAVE AMPLITUDE FLUCTUATION. ADDITIONAL REVIEW OF TRANSMISSIONS REVEALED OVERSENSING OF T WAVES. TS RECOMMENDED BRINGING THE PATIENT INTO THE CLINIC TO MEASURE THE AMPLITUDE OF THE T WAVES. THERE WAS NO PACING INHIBITION FROM THE OVERSENSING. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2684722 | INGEVITY? MRI | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7732 | 1032567 | 00802526523335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Unknown |