FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS VR
MDR report key: 1042866
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33785
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 22, 2008
- Report Date
- February 22, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T135 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | THE DEVICE 1600/750981 WAS IMPLANTED 06-AUG-1992| THE DEVICE 0184/100954 WAS IMPLANTED 03-MAY-2004| THE DEVICE 0040/109088 WAS IMPLANTED 06-AUG-1992| THE DEVICE 0041/208926 WAS IMPLANTED 06-AUG-1992| THE DEVICE 1645/800475 WAS IMPLANTED 04-APR-1997| THE DEVICE 4320/000622 WAS IMPLANTED 06-AUG-1992| THE DEVICE 4320/000599 WAS IMPLANTED 06-AUG-1992 |