FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3 RF HE
MDR report key: 1253805
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40698
- 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
- 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 HE | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H217 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | THE DEVICE 4543/119433 WAS IMPLANTED 07-JUL-2006| THE DEVICE 0185/146251 WAS IMPLANTED 07-JUL-2006| THE DEVICE 4470/514489 WAS IMPLANTED 07-JUL-2006| THE DEVICE 6482 008810 WAS USED DURING THE EVENT. |