FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 3
MDR report key: 1043558
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33079
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 1, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/53-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 3 | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | H170 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | THE DEVICE 0158/137798 WAS IMPLANTED 01-APR-2004| THE DEVICE 6481 051331 WAS USED DURING THE EVENT.| THE DEVICE 4537/152170 WAS IMPLANTED 01-APR-2004| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4087/211233 WAS IMPLANTED 01-APR-2004 |