FDA Adverse Event
Injury
Summary report: N
FINELINE II
MDR report key: 711815
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-14431
- Event Type
- Injury
- Date Received
- May 9, 2006
- Date of Event
- March 20, 2006
- Report Date
- March 20, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- DTB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS LEAD WAS FOUND TO AN INCREASED THRESHOLD MEASUREMENT OF OVER 5.0V AND THE R WAVE AMPLITUDE DECREASED TO 3.0 MV. X-RAY REVEVEALED THAT THE LEAD WAS STRETCHED, AND DID NOT HAVE ENOUGH SLACK AND WAS DISLODGED. THE LEAD WAS REPOSITIONED AND IS NOW WORKING PROPERLY.
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 | NA | Required Intervention |