BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1953663 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23783
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 25, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT THAT THE LEFT VENTRICULAR (LV) LEAD HAD SHIFTED AND WAS REPROGRAMMED DURING A FOLLOW UP VISIT. A FEW WEEKS PRIOR TO THE VISIT SHE WAS EXPERIENCING SHORTNESS OF BREATH. THE LOCAL SALES REPRESENTATIVE HAD CONFIRMED THAT THE LV LEAD HAD PULLED BACK AND THE THRESHOLD WERE SLIGHTLY ELEVATED. THERE WAS NO DIAPHRAGMATIC STIMULATION AND NO OTHER PATIENT SYMPTOMS. THE PHYSICIAN WILL CONTINUE TO MONITOR.

    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 43 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)