FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1043459
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33176
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 5, 2008
- Report Date
- February 5, 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 | H179 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | THE DEVICE 425-/T1L100 WAS IMPLANTED 24-JUN-1999| THE DEVICE 4017/BIR135 WAS IMPLANTED 31-JUL-2001| THE DEVICE 0158/122671 WAS IMPLANTED 14-OCT-2003| THE DEVICE A155/108154 WAS IMPLANTED 21-JUL-2004| THE DEVICE 4518/315242 WAS IMPLANTED 23-JAN-2006 |