FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 1013563
·
Received March 10, 2008
Report
- Report Number
- 2649622-2008-00857
- Event Type
- Injury
- Date Received
- March 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- Z-0067-007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
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 | 41 YR | Required Intervention | D153ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |