FDA Adverse Event
Malfunction
Summary report: N
VITALITY EL
MDR report key: 1043493
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33154
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 5, 2008
- Report Date
- February 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- 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 EL | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T127 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | THE DEVICE 0157/117303 WAS IMPLANTED 01-MAR-2004| THE DEVICE 1298/864339 WAS IMPLANTED 06-AUG-2002 |