FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1072748
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03312
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- June 13, 2006
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- Z-0067-007
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6949 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |