FDA Adverse Event
Injury
Summary report: N
VENTAK PRIZM 2 DR
MDR report key: 1042470
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34173
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 6, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- Z0906-05
- Adverse Event
- 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 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1861 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | THE DEVICE 0049/202589 WAS IMPLANTED 14-JUN-2001| THE DEVICE 0148/106451 WAS IMPLANTED 01-MAR-2001| THE DEVICE 4464/203289 WAS IMPLANTED 01-MAR-2001 |