FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 1072172
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00210
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 21, 2008
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6936 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |