FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
MDR report key: 17517562
·
Received August 11, 2023
Report
- Report Number
- MW5124510
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- July 13, 2012
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE DEVICE WAS IMPLANTED ON (B)(6)2008 AND EXPLANTED ON (B)(6)2012. DUE TO ADVISORY/RECALL. THE PROCEDURE TOOK PLACE AT CEDARS SINAI MEDICAL CENTER. THE PHYSICIAN WAS DR (B)(6). 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 |
|---|---|---|---|---|---|---|---|
| 762434 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | ST. JUDE MEDICAL | V265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |