FDA Adverse Event
Injury
Summary report: N
VITALITY 2 DR
MDR report key: 1042073
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34560
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | THE DEVICE 0185/121702 WAS IMPLANTED 20-APR-2005| THE DEVICE T180/214172 WAS IMPLANTED 17-MAR-2008| THE DEVICE 4470/470043 WAS IMPLANTED 20-APR-2005 |