BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2151448 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06224
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE LEAD HAS NOT BEEN RETURNED. IF THIS LEAD SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS REPORT WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED. THERE WERE SET SCREW MARKS NOTED, TWO ON THE TERMINAL PIN, AND ONE ON THE RING. THERE WAS DRIED BLOOD/BODY FLUID NOTED IN THE LUMEN. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED LOSS OF CAPTURE AND WAS FOUND TO BE DISLODGED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED AS A RESULT OF THE CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4473| 4517| H175| N118| 0184