FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 2
MDR report key: 1041793
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34840
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 20, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z0907/8-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 2 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H155 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | THE DEVICE T165/140257 WAS IMPLANTED 20-MAR-2008| THE DEVICE 0125/212494 WAS IMPLANTED 11-AUG-1996| THE DEVICE 4064/306365 WAS IMPLANTED 13-AUG-2003 |