FDA Adverse Event
Summary report: N
RIATA
MDR report key: 2942129
·
Received January 30, 2013
Report
- Report Number
- 2942129
- Date Received
- January 30, 2013
- Report Date
- January 30, 2013
- Manufacturer
- ST JUDE MEDICAL
- Product Code
- LWS
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
THIS WAS A RECALLED LEAD FOR A BI V ICD THAT WAS TAKEN OUT OF A PATIENT AND REPLACED WITH ANOTHER LEAD FROM THE SAME COMPANY. DURING THE PROCEDURE THE LEAD IN QUESTION WAS FOUND TO NOT HAVE ANY OF THE CONTRIBUTING AFFECTS THAT IS MENTIONED IN THE RECALL. BUT THE LEAD WAS TAKEN OUT OF THE PATIENT... THE LEAD IN THE RECALL IS KNOWN FOR MARKED EXTERNALIZED CONDUCTORS ON THE RV LEAD BETWEEN THE PROXIMAL COIL AND DISTAL COIL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?KNOWN LEAD REVISION AND GENERATOR CHANGE OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41721 | RIATA | IMPLANTABLE, CARDIOVERTER, DEFIBRILLATOR | LWS | ST JUDE MEDICAL | 1581 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |