BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1851802 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14210
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED, IT WAS SEVERED 47 CM FROM THE TERMINAL PIN. VISUAL INSPECTION REVEALED THAT ALL 3 WIRES WERE FRACTURED AT 46 CM FROM THE TERMINAL PIN. THERE WAS NO OBVIOUS SIGN OF SUTURE SLEEVE FOOTPRINTS OBSERVED ON THE INSULATION. THE PROXIMAL SEGMENT OF THE LEAD EXHIBITED BENT INSULATION AT 46 CM FROM THE TERMINAL PIN ON THE SIDE THE FRACTURE HAD OCCURRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD FRACTURED. THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 0184| H179| 4087| 4548| 4518| N119