BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR

    MDR report key: 4092116 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05042
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 22, 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
    FR
    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: THE HELIX EXTENSION LENGTH WAS ACCORDING TO THE SPECIFICATION. DRIED BODY FLUID INSIDE THE INNER INSULATION PREVENTED THE INNER COIL ROTATION WHICH PREVENTED THE HELIX ACTUATION. HELIX COULD BE FULLY AND NORMALLY EXTENDED AND RETRACTED ON A SHORT LENGTH OF LEAD. NORMAL ELECTRICAL CHARACTERISTICS WERE NOTED FOR THE RETURNED LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD COULD NOT BE SECURED INTO THE TISSUE DURING IMPLANTATION. THE LEAD WAS REMOVED AND RETURNED. A DIFFERENT LEAD WAS IMPLANTED AND NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22522 DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7122Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1