BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3881220 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02154
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 3, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THE REPORTED FIELD EVENT OF HELIX ANOMALY AS WELL AS SENSING AND THRESHOLD ANOMALIES WAS NOT CONFIRMED IN THE LABORATORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ABOUT TEN DIFFERENT PLACING MANEUVERS WERE UNDERTAKEN BUT SENSING OR THRESHOLD RESULTS WERE NOT ACCEPTABLE. IT WAS SEEN IN FLUOROSCOPY THAT THE SCREW WAS NO LONGER WORKING. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24412 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7122Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1