BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3212894 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09669
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 4, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED. VISUAL INSPECTION NOTED THAT THE INSULATION WAS CUT HALF WAY AND TORN AROUND THE REST OF THE CIRCUMFERENCE JUST DIAL OF THE TERMINAL ANODAL RING. THE COILS IN THAT AREA ARE DEFORMED. THE LEAD WAS STRETCHED TOWARDS THE DISTAL END TO THE POINT OF A FRACTURE. THE ALLEGATION WAS CONFIRMED THAT THE LEAD WAS FRACTURE.

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS, THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REPLACEMENT PROCEDURE OF THE DEVICE WHEN APPLYING PRESSURE ON THE RIGHT VENTRICULAR LEAD TO REMOVE THE LEAD FROM THE OLD DEVICE INSULATION DAMAGE WAS NOTED AND THE INNER COILS WERE STRETCHED. FURTHER INSPECTION OF THIS LEAD REVEALED THAT THE LEAD FRACTURED. A NEW LEAD WAS IMPLANTED WHILE THIS LEAD WAS EXTRACTED AND WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312753 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR