FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3 RF
MDR report key: 1041543
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31988
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- September 21, 2007
- Report Date
- January 22, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- NA
- 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 | 61 YR | Other | THE DEVICE 4517/430582 WAS IMPLANTED 20-SEP-2007| THE DEVICE 0157/132687 WAS IMPLANTED 20-SEP-2007| THE DEVICE 4469/485062 WAS IMPLANTED 20-SEP-2007 |