FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1043359
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33272
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 7, 2008
- Report Date
- February 7, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/55-07
- Adverse Event
- 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 | H175 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | THE DEVICE 4513/315849 WAS IMPLANTED 05-AUG-2003| THE DEVICE 0157/111523 WAS IMPLANTED 05-AUG-2003| THE DEVICE 6481 015010 WAS USED DURING THE EVENT.| THE DEVICE 4513/315466 WAS IMPLANTED 05-AUG-2003| THE DEVICE 4086/153091 WAS IMPLANTED 05-AUG-2003| THE DEVICE H115/101148 WAS IMPLANTED 05-AUG-2003 |