BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1946196 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20762
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THESE OBSERVATIONS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY CAPPED AND ABANDONED DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION. THE LV LEAD WAS UNABLE TO CAPTURE AT MAXIMUM PACING OUTPUT, AND CONCERN WAS EXPRESSED THAT THERE MAY HAVE BEEN A LV LEAD MALFUNCTION OR A PROBLEM WITH THE LEAD-TISSUE INTERFACE.

    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 68 YR Other| R H175| MISMATCH| 4518| 4087| 0158