FDA Adverse Event
Death
Summary report: N
KAPPA 700 DR
MDR report key: 1200146
·
Received October 16, 2008
Report
- Report Number
- 2647346-2008-00482
- Event Type
- Death
- Date Received
- October 16, 2008
- Date of Event
- October 6, 2008
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 700 DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KDR701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death | 4524 IMPLANTABLE PACING LEAD |