BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1853538 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14937
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT OFFERED SUGGESTIONS TO TRY DIFFERENT LEAD CONFIGURATIONS AS TROUBLESHOOTING. THE CALLER WILL DISCUSS THE CLINICAL OBSERVATIONS WITH THE PATIENT'S PHYSICIAN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD STARTED EXHIBITING RISING IMPEDANCE MEASUREMENTS ABOUT THREE MONTHS AGO. TODAY, IMPEDANCE IS GREATER THAN 2000 OHMS AND THERE IS NO CAPTURE. THE PATIENT IS NOT SYMPTOMATIC.

    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 86 YR 0158| H225| H155| 4518| 1488TC