FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS
MDR report key: 1042076
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34563
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 17, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY DS | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | THE DEVICE 0148/117252 WAS IMPLANTED 21-FEB-2002| THE DEVICE 4470/312241 WAS IMPLANTED 21-FEB-2002| THE DEVICE E030/500481 WAS IMPLANTED 17-MAR-2008 |