FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1254305
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-41108
- Event Type
- Malfunction
- Date Received
- November 11, 2008
- Date of Event
- September 30, 2008
- Report Date
- September 30, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z1192/94-6
- 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 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H170 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 4549/151786 WAS IMPLANTED 28-SEP-2005| THE DEVICE 0144/334531 WAS IMPLANTED 21-DEC-2001 |