FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1254004
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40867
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 3 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H177 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other | THE DEVICE 0184/133211 WAS IMPLANTED 26-SEP-2008| THE DEVICE 0184/115763 WAS IMPLANTED 12-AUG-2005| THE DEVICE 4542/106362 WAS IMPLANTED 12-AUG-2005| THE DEVICE 0184/152332 WAS IMPLANTED 26-SEP-2008 |