FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1073559
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01999
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- March 12, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE REPORTED OVERSENSING WAS CAUSED BY AN ABRASION TO THE OUTER INSULATION BETWEEN 8.2 CM AND 9.8 CM FROM THE CONNECTOR PIN DUE TO FRICTION WITH THE PACEMAKER CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED OVERSENSING. IT WAS POSSIBLE TO PRODUCE MYOPOTENTIAL. A REVISION WAS UNSUCCESSFULLY ATTEMPTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |