BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1950532 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22646
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    July 7, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED IN INSULATION, AND SETSCREW MARKS WERE NOTED. THE LEAD PASSED ELECTRICAL TESTING. LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LV LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THIS LEAD WAS EXPLANTED DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP LOSS OF CAPTURE WITH ASYSTOLE, OVERSENSING OF THE ATRIAL CHANNEL, AND INCREASE IN THRESHOLDS WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD. AN LV LEAD DISLODGEMENT WAS NOTED. A REPOSITIONING PROCEDURE HAS BEEN SCHEDULED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR