BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3890972 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03647
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 7, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HELIX WOULD NOT EXTEND FULLY OR RETRACT. THRESHOLDS WERE TESTED AFTER PARTIAL DEPLOYMENT OF THE HELIX AND WERE NOT IN ACCEPTABLE RANGE. A NEW LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24584 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATOR LEAD, NVY NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7121Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1