FDA Adverse Event
Injury
Summary report: N
VITALITY AVT
MDR report key: 1042517
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34124
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
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 | 64 YR | Required Intervention | THE DEVICE 4016/BIQ109 WAS IMPLANTED 11-APR-2000| THE DEVICE 1851/302889 WAS IMPLANTED 11-APR-2000 |