FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 1253579
·
Received November 11, 2008
Report
- Report Number
- 2124215-2008-40302
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 8, 2008
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINELINE II | IMPLANTABLE LEAD | DTB | CARDIAC PACEMAKERS, INC | 4457 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | THE DEVICE 1194/129828 WAS IMPLANTED 17-FEB-2005 |