FDA Adverse Event
Malfunction
Summary report: N
VENTAK PRIZM HE VR
MDR report key: 1254239
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40830
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK PRIZM HE VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1852 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | THE DEVICE 1746/604198 WAS IMPLANTED 12-DEC-1997| THE DEVICE 1625/300221 WAS IMPLANTED 02-MAR-1994| THE DEVICE 4471/438126 WAS IMPLANTED 14-JUL-2006| THE DEVICE 6952/202309 WAS IMPLANTED 25-FEB-2005| THE DEVICE T175/100290 WAS IMPLANTED 25-FEB-2005| THE DEVICE 0187/100039 WAS IMPLANTED 25-FEB-2005| THE DEVICE 1857/702834 WAS IMPLANTED 18-JUN-2004| THE DEVICE 0064/005799 WAS IMPLANTED 02-MAR-1994 |