FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1042209
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34444
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 14, 2008
- Report Date
- March 14, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 | H170 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | THE DEVICE 0184/119662 WAS IMPLANTED 20-APR-2006| THE DEVICE 4480/307702 WAS IMPLANTED 19-JUN-2002| THE DEVICE 4542/111477 WAS IMPLANTED 20-APR-2006| THE DEVICE 1298/102742 WAS IMPLANTED 19-JUN-2002| THE DEVICE 4457/326670 WAS IMPLANTED 19-JUN-2002 |