BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 3905782 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10982
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    March 30, 2006
    Report Date
    May 13, 2014
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED LEAD SEGMENT WAS PERFORMED. VISUAL INSPECTION NOTED AN INSULATION ABRASION THROUGH TO THE ANODE CONDUCTOR COIL 88-92MM FROM THE TERMINAL PIN. RESISTANCE TESTING CONFIRMED THE LEAD SEGMENT TO BE ELECTRICALLY CONTINUOUS. DUE TO THE TYPE OF THE ABRASION, IT WAS LIKELY THIS WAS CAUSED BY LEAD-ON-LEAD INTERACTION. AN INSULATION ABRASION THROUGH TO A SENSING CONDUCTOR COULD CAUSE THE REPORTED ALLEGATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS QUESTIONED WHETHER THIS SINGLE CHAMBER PACING SYSTEM WAS FUNCTIONING APPROPRIATELY UPON REVIEW OF ELECTROCARDIOGRAMS. THE ELECTROCARDIOGRAMS WERE REVIEWED AND THE SYSTEM WAS DETERMINED TO BE FUNCTIONING APPROPRIATELY AS PROGRAMMED IN AAI MODE. THE SYSTEM REMAINED IMPLANTED AT THE TIME OF THE OBSERVATIONS AND THE DEVICE WAS RETURNED EIGHT YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382619 TRANSVENOUS IMPLANTABLE LEAD LWS HISTORICAL PUERTO RICO 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4261| 1124