FDA Adverse Event
Malfunction
Summary report: N
VITALITY DS VR
MDR report key: 1041435
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32103
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- January 3, 2008
- Report Date
- January 3, 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 DS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T135 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | THE DEVICE 6481 014491 WAS USED DURING THE EVENT.| THE DEVICE 0158/132192 WAS IMPLANTED 12-FEB-2004| THE DEVICE 0157/121152 WAS IMPLANTED 09-FEB-2004| THE DEVICE 1740/100634 WAS IMPLANTED 02-FEB-1996| THE DEVICE 0115/203512 WAS IMPLANTED 02-FEB-1996| THE DEVICE 1790/108256 WAS IMPLANTED 02-JUN-2000| THE DEVICE 1860/130819 WAS IMPLANTED 09-FEB-2004 |