FDA Adverse Event
Malfunction
Summary report: N
FINELINE II
MDR report key: 1042318
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-34329
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 11, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4472 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | THE DEVICE 1290/788913 WAS IMPLANTED 11-MAR-2008| THE DEVICE 1298/205313 WAS IMPLANTED 05-JUL-2005| THE DEVICE 4135/282706 WAS IMPLANTED 11-MAR-2008| THE DEVICE 4136/282734 WAS IMPLANTED 11-MAR-2008| THE DEVICE 4473/429195 WAS IMPLANTED 05-JUL-2005 |