FDA Adverse Event
Injury
Summary report: N
TRANSVENE
MDR report key: 1072250
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00179
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 30, 2008
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6933 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6936 IMPLANTABLE TACHY LEAD |