FDA Adverse Event
Injury
Summary report: N
GEM III AT
MDR report key: 1072384
·
Received July 10, 2008
Report
- Report Number
- 6000094-2008-00236
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 9, 2007
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEM III AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC S.A. | 7276 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |