FDA Adverse Event
Malfunction
Summary report: N
SPRINT FIDELIS
MDR report key: 1180323
·
Received September 17, 2008
Report
- Report Number
- 1180323
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- July 25, 2008
- Report Date
- September 14, 2008
- Manufacturer
- MEDTRONIC INC, CARDIAC RHYTHM DISEASE MANAGEMENT
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE LEAD FRACTURED. IT WAS REMOVED AND REPLACED WITH ANOTHER LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | LEAD, ICD | LWS | MEDTRONIC INC, CARDIAC RHYTHM DISEASE MANAGEMENT | 6949-65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |