FDA Adverse Event
Malfunction
Summary report: N
CONTAK RENEWAL 4 AVT HE
MDR report key: 1043078
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33578
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 15, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- Z47/55-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL 4 AVT HE | IMPLANTABLE CHF GENERATOR | NIK | CARDIAC PACEMAKERS, INC | M177 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | THE DEVICE 0185/190168 WAS IMPLANTED| THE DEVICE 6949 LFJ103 WAS USED DURING THE EVENT.| THE DEVICE 4096/PJN972 WAS IMPLANTED| THE DEVICE 4194/LFG101 WAS IMPLANTED| THE DEVICE H190/315159 WAS IMPLANTED |