BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD, DF4 CONNECTOR

    MDR report key: 4092128 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05040
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 18, 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
    IT
    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. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT DIFFERENT POSITIONS OF THE LEAD WERE ATTEMPTED IN OF THE RIGHT VENTRICLE TO ACHIEVE A HIGHER VALUE OF VENTRICULAR SENSING. THE PHYSICIAN NOTICED THAT IT WAS DIFFICULT TO INSERT STYLET IN RV LEAD. ON FLUOROSCOPY IMAGE THE PHYSICIAN NOTICED THAT THERE WAS A PROBLEM ON THE SCREW OF LEAD, IT WAS IMPOSSIBLE TO EXPOSE IT COMPLETELY. THIS LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22513 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