FDA Adverse Event
Injury
Summary report: N
COGNIS HE IS-1/DF-1/IS-1
MDR report key: 1254063
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40895
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- September 24, 2008
- Report Date
- September 24, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- NIK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COGNIS HE IS-1/DF-1/IS-1 | IMPLANTABLE CHF PULSE GENERATOR | NIK | CARDIAC PACEMAKERS, INC | N119 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | THE DEVICE 0184/151797 WAS IMPLANTED 17-SEP-2008| THE DEVICE 4554/166784 WAS IMPLANTED 17-SEP-2008 |