FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL 4
MDR report key: 1002405
·
Received February 7, 2008
Report
- Report Number
- 2124215-2008-31900
- Event Type
- Injury
- Date Received
- February 7, 2008
- Date of Event
- September 28, 2007
- Report Date
- September 28, 2007
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
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 | Required Intervention | THE DEVICE 0158/169022 WAS IMPLANTED| THE DEVICE 0158/169022 WAS IMPLANTED |