FDA Adverse Event
Malfunction
Summary report: N
DYNAGEN CRT-D
MDR report key: 21170055
·
Received January 16, 2025
Report
- Report Number
- 2124215-2025-01805
- Event Type
- Malfunction
- Date Received
- January 16, 2025
- Date of Event
- December 19, 2024
- Report Date
- January 16, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIK
- UDI-DI
- 00802526534614
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT FELT LIKE THERE IS A LITTLE DENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AFTER THE PATIENT HIT AN ELK WITH HIS CAR. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 891941 | DYNAGEN CRT-D | CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR | NIK | BOSTON SCIENTIFIC CORPORATION | G150 | 507050 | 00802526534614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |