FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3 RF
MDR report key: 1043056
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33585
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 18, 2008
- Report Date
- February 18, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z-0863-05
- 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 RF | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H215 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | THE DEVICE 1184/321647 WAS IMPLANTED 22-MAR-2004| THE DEVICE 6483 507020 WAS USED DURING THE EVENT.| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6482 012555 WAS USED DURING THE EVENT.| THE DEVICE 6487 506020 WAS USED DURING THE EVENT.| THE DEVICE 4088/204589 WAS IMPLANTED 22-MAR-2004| THE DEVICE 4518/325316 WAS IMPLANTED 26-JAN-2007| THE DEVICE 4525/159743 WAS IMPLANTED 26-JAN-2007| THE DEVICE 0158/156163 WAS IMPLANTED 26-JAN-2007 |