FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1042731
·
Received May 8, 2008
Report
- Report Number
- 2124215-2008-33902
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4470 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | THE DEVICE 1296/144053 WAS IMPLANTED 26-FEB-2008| THE DEVICE 1297/308085 WAS IMPLANTED 28-DEC-2005| THE DEVICE 4086/230892 WAS IMPLANTED 28-DEC-2005| THE DEVICE 4088/222562 WAS IMPLANTED 26-FEB-2008 |