FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3101104
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01882
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 22, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 6.6CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RV LEAD NO LONGER PROVIDED PACING OUTPUT. THE PATIENT IS AN ACTIVE SOCCER PLAYER. LEAD FRACTURE WAS OBSERVED ON THE RA LEAD. IT WAS NOT POSSIBLE TO EXPLANT THE RV LEAD. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204503 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |