FDA Adverse Event
Malfunction
Summary report: N
PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 17532868
·
Received August 12, 2023
Report
- Report Number
- MW5139774
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- June 20, 2017
- Manufacturer
- MEDTRONIC
- Product Code
- NVY
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS RV LEAD WAS IMPLANTED ON (B)(6) 1999 AND REMAINS IMPLANTED AT THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON 04/20/2017 STATING THAT SHOCK LEAD IMPEDANCE OUT OF RANGE 125. TREND APPEARS TO HAVE BEEN IN THE 900 - 110'S RANGE RECENTLY. ALSO REVIEW OPTIONS FOR ALERT TRIGGER OF 150, 175 AND 200 OHMS. 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 |
|---|---|---|---|---|---|---|---|
| 728925 | PERMANENT DEFIBRILLATOR ELECTRODES | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MEDTRONIC | 6943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |