FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1042310
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34321
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 7, 2008
- Report Date
- March 7, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
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 | 80 YR | Required Intervention | THE DEVICE 4548/153135 WAS IMPLANTED 24-MAR-2006| THE DEVICE 4087/253931 WAS IMPLANTED 24-MAR-2006| THE DEVICE 0184/129439 WAS IMPLANTED 09-NOV-2006| THE DEVICE H210/217758 WAS IMPLANTED 07-MAR-2008| THE DEVICE 0184/145256 WAS IMPLANTED 07-MAR-2008| THE DEVICE 0184/121725 WAS IMPLANTED 24-MAR-2006 |