FDA Adverse Event
Injury
Summary report: N
PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 17532018
·
Received August 12, 2023
Report
- Report Number
- MW5138929
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- December 17, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- NVY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
INFORMATION RECEIVED ON (B)(6) 2013 STATES THAT PATIENT HAD EROSION. UNSURE OF THE LEAD STATUS. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6). NOO THER INFORMATION IS AVAILABLE. INFORMATION RECEIVED ON (B)(6) 2013 STATES THAT THIS LEAD WAS CAPPED ON (B)(6) 2013 DUE TO EPISODES OF NOTED. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940243 | PERMANENT DEFIBRILLATOR ELECTRODES | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MEDTRONIC | 4074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |