FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 1041601
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31934
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- June 29, 2006
- Report Date
- March 19, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z1288/92-6
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
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 | 75 YR | Other | THE DEVICE T165/140432 WAS IMPLANTED 10-MAR-2008| THE DEVICE 0185/133949 WAS IMPLANTED 29-MAR-2006| THE DEVICE 4470/502198 WAS IMPLANTED 29-MAR-2006 |