FDA Adverse Event
Malfunction
Summary report: N
VITALITY AVT
MDR report key: 1041449
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32089
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- January 2, 2008
- Report Date
- January 2, 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 AVT | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | A135 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 4087/159914 WAS IMPLANTED 12-JUN-2003| THE DEVICE 03 / WAS IMPLANTED| THE DEVICE 0158/116077 WAS IMPLANTED 12-JUN-2003 |