FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 VR
MDR report key: 1116744
·
Received August 14, 2008
Report
- Report Number
- 2124215-2008-37186
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 2, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
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 | 81 YR | Other | THE DEVICE T175/130237 WAS IMPLANTED 02-JUN-2008| THE DEVICE 0185/103536 WAS IMPLANTED 04-MAR-2005 |