FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 1072411
·
Received July 10, 2008
Report
- Report Number
- 2647346-2008-00335
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- December 13, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 900 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR903 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention | 1388TC52 COMPETITOR IMPLANTABLE PACING LEAD| 1388TC58 COMPETITOR IMPLANTABLE PACING LEAD |