BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2170260 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09894
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS REPAIRED A YEAR AGO DUE TO DAMAGE THAT OCCURRED TO THE INSULATION DURING A DEVICE REPLACEMENT PROCEDURE. TODAY, IMPEDANCES ARE NOW GREATER THAN 2000 OHMS AND THRESHOLDS HAVE INCREASED. THE PATIENT HAS BEEN SCHEDULED FOR AN LV LEAD REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED AS A RESULT FROM NO BI-VENTRICULAR PACING, HOWEVER SINCE THE IMPEDANCES INCREASED, THE PATIENT HAS FELT MORE FATIGUE, TIRED AND DECREASED ENERGY.

    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 61 YR N118| 4518| 4087| H219| 0148| 1860| 4470| 1853