BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR

    MDR report key: 3881208 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02166
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 7, 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. ELECTRICAL ANALYSIS REVEALED HIGH LEAD PACING IMPEDANCE DUE TO THAT THE HELIX WAS RETRACTED AND CLOGGED WITH DRIED BODY FLUID/TISSUE. NORMAL LEAD PACING IMPEDANCE WAS MEASURED WHEN THE HELIX WAS IN EXTENDED POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPERIENCING HIGH THRESHOLDS AT IMPLANTATION. MULTIPLE ATTEMPTS WERE MADE TO PLACE THE LEAD BUT THE IMPEDANCE VALUES WERE STILL HIGH. THE LEAD WAS REMOVED, RETURNED, AND A NEW LEAD WAS IMPLANTED. ACCEPTABLE THRESHOLD VALUES WERE FOUND WITH A NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24509 DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7122Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1