BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1771323 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12405
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RECENT DEVICE UPGRADE PROCEDURE, IT WAS NOTED THAT THIS LEFT VENTRICULAR LEAD WAS FRACTURED. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 78 YR 4591| H125| 4517| 4245| 0185| N119| 4244