FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1041925
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34720
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/53-08
- Product Problem
- 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 | CONTAK RENEWAL 3 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H177 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other | THE DEVICE 0155/350825 WAS IMPLANTED 26-APR-2002| THE DEVICE 4047/100130 WAS IMPLANTED 07-JUN-2005| THE DEVICE 6481 040657 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4469/305148 WAS IMPLANTED 26-APR-2002 |