FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 1002409
·
Received February 7, 2008
Report
- Report Number
- 2124215-2008-31892
- Event Type
- Malfunction
- Date Received
- February 7, 2008
- Date of Event
- August 6, 2007
- Report Date
- August 6, 2007
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4479 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other | THE DEVICE 1280/533493 WAS IMPLANTED 21-MAY-2002| THE DEVICE 4456/308887 WAS IMPLANTED 21-MAY-2002 |