FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3 RF
MDR report key: 1042516
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34135
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 3 RF | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | THE DEVICE 6483 507020 WAS USED DURING THE EVENT.| THE DEVICE 6487 507020 WAS USED DURING THE EVENT.| THE DEVICE 7001/ABD363 WAS IMPLANTED 10-MAY-2007| THE DEVICE 6482 016704 WAS USED DURING THE EVENT.| THE DEVICE 4262/070426 WAS IMPLANTED 07-APR-1995| THE DEVICE 4269/226388 WAS IMPLANTED 07-APR-1995 |