BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3881232 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02134
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 21, 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
    NC, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A VIBRATORY ALERT FOR HIGH LEAD IMPEDANCE OUT OF RANGE. THE CLINICIAN TURNED THE PATIENT NOTIFIER OFF AND THE PATIENT WAS SENT HOME AND WAS FOLLOWED UP VIA MERLIN.NET. ON SUBSEQUENT FOLLOW UP HVLI REMAINED STABLE AND NO NOISE WAS OBSERVED. LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24511 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 712Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR