BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION LEAD, DF4 CONNECTOR

    MDR report key: 4092087 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05048
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 1, 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
    MS, 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. EVALUATION DESCRIPTION: THE REPORTED EVENT OF CAPTURE ANOMALY WAS NOT CONFIRMED. VISUAL INSPECTION FOUND CUTS IN OUTER INSULATION, CONSISTENT WITH EXPLANT/IMPLANT DAMAGE. THE CAUSE OF THE CAPTURE ANOMALY WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, INTERMITTENT CAPTURE WAS OBSERVED. THE LEAD WAS REMOVED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23152 DURATA STS OPTIM PASSIVE FIXATION LEAD, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7170Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1