BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1851902 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14359
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 22, 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

    THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT HIGH IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS WAS NOTED ON THIS LEFT VENTRICULAR (LV) LEAD. THRESHOLD AND SENSING MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL LIMITS IN ALL PACING CONFIGURATIONS. THE FIELD REPRESENTATIVE STATED HE WILL LEAVE THE LEAD IN LV LEAD TIP TO RIGHT VENTRICULAR (RV) LEAD COIL CONFIGURATION AS EVERYTHING APPEARS NORMAL IN THAT CONFIGURATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LV LEAD WAS SURGICALLY ABANDONED DUE TO HIGH IMPEDANCE MEASUREMENTS AND LEAD FRACTURE DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION (NBD). THE LV LEAD FRACTURE SITE WAS DISTAL TO THE SUTURE WHERE THE LEAD TOOK A SHARP BEND INTO THE VEIN, THIS CREATED A KINK IN THE LEAD AND CAUSED THE LEAD TO FRACTURE. 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 90 YR H170| 4542| 0158