FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 4
MDR report key: 1042242
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34393
- Event Type
- Malfunction
- 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
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
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 | Other | THE DEVICE 4517/423241 WAS IMPLANTED 20-FEB-2006| THE DEVICE 0138/103338 WAS IMPLANTED 20-FEB-2006| THE DEVICE UNKN/ WAS IMPLANTED |