FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC
MDR report key: 17516957
·
Received August 11, 2023
Report
- Report Number
- MW5123906
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- December 6, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT ON (B)(6) 2011 THIS LEAD WAS CONVERTED WITH 41 J INITIALLY. FAILED IN REVERSED POLARITY AND THEN WHEN PROGRAMMED RV COIL TO CAN ABLE TO CONVERT WITH 31 JOULES. REP. STATES THAT ON FLUORO AFTER DFT TESTING IT APPEARED THE MDT SQ ARRAY MAY HAVE FRACTURE. DID NOT HAVE INITIAL X-RAY FOR COMPARISON. REP. IS GOING TO CHECK WITH MDT REP. ON WHAT THE EXPECTED APPEARANCE IS OF THIS CIL. SHOCK IMPEDANCE WERE ALL STABLE AT 33, 33, AND 35 OHMS. SHOCK IMPEDANCE. 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 |
|---|---|---|---|---|---|---|---|
| 868643 | MEDTRONIC | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | MEDTRONIC | 6996SQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |