FDA Adverse Event
Malfunction
Summary report: N
INGEVITY+
MDR report key: 20623410
·
Received November 6, 2024
Report
- Report Number
- 2124215-2024-69850
- Event Type
- Malfunction
- Date Received
- November 6, 2024
- Date of Event
- October 4, 2024
- Report Date
- January 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604577
- PMA / PMN Number
- P150012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING FILED TO REMOVE INCORRECT PATIENT CODE E060102 (H6) AS IT WAS UNRELATED TO THIS EVENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING OF THE PATIENT'S ATRIAL FIBRILLATION. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL UNDERSENSING WITH ATRIAL FIBRILLATION. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1997973 | INGEVITY+ | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | NVN | BOSTON SCIENTIFIC CORPORATION | 7841 | 1313994 | 00802526604577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female |