BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2053510 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04656
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS NO CHANGES WERE MADE TO THE PATIENT'S SYSTEM AND THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LEFT VENTRICULAR (LV) PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE OBSERVED VIA LATITUDE. THE PATIENT WAS SEEN IN CLINIC AND LV IMPEDANCE MEASUREMENTS WERE 800 OHMS. ATTEMPTS TO RECREATE OUT OF RANGE MEASUREMENTS WERE UNSUCCESSFUL. 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 4517

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR MISMATCH| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)