BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1864015 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15704
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT TO ELECTRONIC REPOSITION THIS LEAD WILL BE MADE AT A FUTURE DATE. AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. AS A RESULT OF THE HIGH PACING THRESHOLDS, THE ASSOCIATED DEVICE WILL BE EXPLANTED. DURING THE REPLACEMENT PROCEDURE, THIS LV LEAD WILL BE EXPLANTED AS WELL. IT IS UNKNOWN IF IT WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PACING THRESHOLDS ON THIS LEFT VENTRICULAR (LV) LEAD HAD BEEN INCREASING SINCE DECEMBER. IT IS BELIEVED THAT THIS LEAD HAD DISLODGED. 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 Other