FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1042126
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34529
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 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 | 83 YR | Other | THE DEVICE 6942 TCB102 WAS USED DURING THE EVENT.| THE DEVICE 6481 038173 WAS USED DURING THE EVENT.| THE DEVICE 4046/101824 WAS IMPLANTED 17-AUG-2005| THE DEVICE 4088/156229 WAS IMPLANTED 27-JUN-2003 |