FDA Adverse Event
Injury
Summary report: N
VITALITY DS
MDR report key: 1042290
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34357
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 10, 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 DS | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | THE DEVICE 4054/421403 WAS IMPLANTED 04-APR-2002| THE DEVICE 1861/222591 WAS IMPLANTED 04-APR-2002| THE DEVICE 1790/109399 WAS IMPLANTED 27-DEC-2000| THE DEVICE 0154/341465 WAS IMPLANTED 27-DEC-2000 |