FDA Adverse Event
Malfunction
Summary report: N
SPECTRAFLEX
MDR report key: 1072435
·
Received July 10, 2008
Report
- Report Number
- 6000022-2008-00004
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Manufacturer
- MEDTRONIC FRANCE S.A.
- Product Code
- DTB
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRAFLEX | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC FRANCE S.A. | 6957J | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |