FDA Adverse Event
Malfunction
Summary report: N
PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 17533985
·
Received August 12, 2023
Report
- Report Number
- MW5140888
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 15, 2022
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A RED ALERT WAS RECORDED DUE TO A HIGH SHOCK IMPEDANCE MEASUREMENT OUT-OF-RANGE. TECHNICAL SERVICES RECOMMENDED THE CLINIC TO CALL THE PATIENT AND PERFORM A PATIENT-INITIATED INVESTIGATION ON THIS CASE, ALSO TO TRY REPRODUCING THE MEASUREMENTS AND CHECK OTHER VECTORS, AS THE SHOCK IMPEDANCE HAS SHOWN ODR MEASUREMENTS FOR THE LAST COUPLE OF DAYS. NO NOISY SIGNALS WERE NOTICED. THIS RV LEAD REMAINS IN SERVICE AND NO ADVENT PATIENT EFFECTS WERE REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 727998 | PERMANENT DEFIBRILLATOR ELECTRODES | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | ST. JUDE MEDICAL | 7121Q | BJX12741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |