FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1041591
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31952
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 1, 2007
- Report Date
- March 10, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 | H179 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other | THE DEVICE 4470/355526 WAS IMPLANTED 04-SEP-2003| THE DEVICE 4513/314654 WAS IMPLANTED 04-SEP-2003| THE DEVICE H219/206754 WAS IMPLANTED 20-FEB-2008| THE DEVICE 0157/103246 WAS IMPLANTED 04-SEP-2003 |