FDA Adverse Event
Injury
Summary report: N
VITALITY 2 DR
MDR report key: 1042336
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34318
- 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
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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 | Required Intervention | THE DEVICE T165/141386 WAS IMPLANTED 05-MAR-2008| THE DEVICE 0184/145642 WAS IMPLANTED 29-FEB-2008| THE DEVICE 4086/247480 WAS IMPLANTED 29-FEB-2008 |