FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 4 RF
MDR report key: 1042227
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34406
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 12, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 4 RF | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H235 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | THE DEVICE 0148/131440 WAS IMPLANTED 28-FEB-2003| THE DEVICE 4518/201858 WAS IMPLANTED 28-FEB-2003| THE DEVICE 6501 WAS USED DURING THE EVENT.| THE DEVICE 0148/ WAS IMPLANTED |