FDA Adverse Event
Injury
Summary report: N
GEM III VR
MDR report key: 1013537
·
Received March 10, 2008
Report
- Report Number
- 2647346-2008-00084
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- March 2, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEM III VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7231CX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other | 6943 IMPLANTABLE TACHY LEAD |