FDA Adverse Event
Malfunction
Summary report: N
VITALITY VR
MDR report key: 1042974
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33671
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 19, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1870 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | THE DEVICE 1793/300189 WAS IMPLANTED 12-MAY-1999| THE DEVICE T175/132929 WAS IMPLANTED 19-FEB-2008| THE DEVICE 5024 LAT264 WAS USED DURING THE EVENT.| THE DEVICE 0125/000414 WAS IMPLANTED 22-MAY-1995| THE DEVICE 1720/251078 WAS IMPLANTED 22-MAY-1995 |