BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2041502 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00957
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THIS LEAD REMAINING IMPLANTED NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING POST IMPLANT FOLLOW UP THE LEFT VENTRICULAR PACING IMPEDANCES HAD INCREASED AND IN THE DAILY MEASUREMENTS TWO IMPEDANCES MEASUREMENTS WERE OUT OF RANGE. IT WAS REPORTED THAT THE DEVICE IS WORKING PROPERLY AND THE PATIENT IS NOT PACEMAKER DEPENDENT. THE PHYSICIAN ELECTED TO EVALUATE THE LEAD AT THE NEXT SCHEDULED FOLLOW UP. 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 4542

    Patients

    Seq Age Sex Outcome Treatment
    1