FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 1254236
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40755
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 18, 2008
- Report Date
- September 18, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z47/53-08
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 | 66 YR | Other | THE DEVICE 4086/234787 WAS IMPLANTED 10-MAY-2006| THE DEVICE T165/144506 WAS IMPLANTED 19-SEP-2008| THE DEVICE 0184/151636 WAS IMPLANTED 19-SEP-2008| THE DEVICE 4086/250276 WAS IMPLANTED 19-SEP-2008| THE DEVICE 0184/123753 WAS IMPLANTED 10-MAY-2006 |