FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INC.
MDR report key: 808540
·
Received January 3, 2007
Report
- Report Number
- 808540
- Event Type
- Injury
- Date Received
- January 3, 2007
- Date of Event
- September 27, 2006
- Report Date
- December 29, 2006
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DXY
- Report Source
- User Facility report
- Reporter Location
- HI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC INC. | GENERATOR | DXY | MEDTRONIC INC. | 7278 | * | |
| 2 | MEDTRONIC INC. | LEAD | DTB | MEDTRONIC INC. | 4568-53 | * | |
| 3 | MEDTRONIC INC | LEAD | DTB | MEDTRONIC INC. | 6936-65 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |