FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 VR
MDR report key: 1115632
·
Received August 14, 2008
Report
- Report Number
- 2124215-2008-35405
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 4, 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 2 VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T175 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE T177/114123 WAS IMPLANTED 03-APR-2008| THE DEVICE 0165/103750 WAS IMPLANTED 04-FEB-2005| THE DEVICE 0181/108951 WAS IMPLANTED 03-APR-2008 |