BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 4172438 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01789
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 11, 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 Location
    NC, US
    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. EVAL: THE REPORTED FIELD EVENT OF LOW PACING IMPEDANCE AND CAPTURE ANOMALY WERE NOT CONFIRMED. THE ELECTRICAL PROPERTIES OF THE LEAD WERE EVALUATED AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT THIS LEAD DISPLAYED LOW PACING IMPEDANCE DESPITE TRYING DIFFERENT LOCATIONS. SENSING AND PACING VALUES WERE NORMAL. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29144 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7122Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR