FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 VR
MDR report key: 1041791
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34865
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 27, 2008
- Report Date
- March 27, 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
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T175 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 0157/122286 WAS IMPLANTED 18-JAN-2006| THE DEVICE 0148/118870 WAS IMPLANTED 21-MAR-2002 |