BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3911768 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-10699
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAS PULLED BACK INTO THE RIGHT ATRIUM (RA). THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO VERIFY IF LV PACING WAS PROGRAMMED OFF AND INQUIRED HOW TO PROGRAM THE PERSISTENT LV PACE MARKERS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE PARAMETERS FOR PROGRAMMING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. AT THIS TIME, THE LV LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391131 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR N160| 0292| 4470| K173| 4542| 4469