FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 1041533
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32006
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- October 30, 2007
- Report Date
- March 24, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | THE DEVICE 0125/212972 WAS IMPLANTED 21-AUG-1996| THE DEVICE 4473/308005 WAS IMPLANTED 24-JUN-2002| THE DEVICE 4472/302856 WAS IMPLANTED 24-JUN-2002 |