FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 3 RF
MDR report key: 1041722
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34909
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 28, 2008
- Report Date
- March 28, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- 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 RF | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | THE DEVICE 4543/130343 WAS IMPLANTED 18-DEC-2007| THE DEVICE 4470/520207 WAS IMPLANTED 18-DEC-2007| THE DEVICE 0185/186441 WAS IMPLANTED 18-DEC-2007 |