FDA Adverse Event
Injury
Summary report: N
MDT SPRINT FIDELIS
MDR report key: 1091044
·
Received August 1, 2008
Report
- Report Number
- MW5007867
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- March 22, 2008
- Manufacturer
- MEDTRONIC INC.
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS FOUND TO HAVE INCREASED IMPEDANCE FROM 400-500'S TO 1500'S ON ICD LEAD. THIS WAS A RECALLED LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MDT SPRINT FIDELIS | ICD LEAD | LWS | MEDTRONIC INC. | 6949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization |