FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 VR EL
MDR report key: 1041494
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32050
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- December 20, 2007
- Report Date
- January 18, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 VR EL | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T177 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE T177/113772 WAS IMPLANTED 21-DEC-2007| THE DEVICE 0185/164728 WAS IMPLANTED 06-JUL-2007| THE DEVICE 0185/164791 WAS IMPLANTED 06-JUL-2007 |