FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1042196
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34446
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 14, 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 | H179 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | THE DEVICE 4518/308244 WAS IMPLANTED 28-DEC-2004| THE DEVICE H175/509859 WAS IMPLANTED 28-DEC-2004| THE DEVICE 4470/443213 WAS IMPLANTED 28-DEC-2004| THE DEVICE 6481 008541 WAS USED DURING THE EVENT.| THE DEVICE 0158/149258 WAS IMPLANTED 28-DEC-2004 |