FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 4
MDR report key: 1041514
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-32015
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- November 17, 2007
- Report Date
- March 5, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/53-08
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 4 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H195 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | THE DEVICE 4087/171613 WAS IMPLANTED 18-NOV-2004| THE DEVICE 0158/146494 WAS IMPLANTED 18-NOV-2004| THE DEVICE 4518/301090 WAS IMPLANTED 18-NOV-2004 |