FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 4
MDR report key: 1041632
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-31910
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- August 15, 2005
- Report Date
- March 31, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 4 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H190 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE 0174/101732 WAS IMPLANTED 21-APR-2005| THE DEVICE H190/310262 WAS IMPLANTED 16-AUG-2005| THE DEVICE 4470/425391 WAS IMPLANTED 21-APR-2005 |