FDA Adverse Event
Injury
Summary report: N
KAPPA 700 SR
MDR report key: 1072840
·
Received July 10, 2008
Report
- Report Number
- 2647346-2008-00301
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- July 5, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAPPA 700 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | KSR701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other | 4269 NON-MEDTRONIC IMPLANTABLE PACING LEAD |