BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1944671 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20125
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF THE ANALYSIS PROCESS, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD SUDDENLY BROKE DURING THE ATTEMPTED IMPLANT PROCEDURE. AS A RESULT, THE PRODUCT WAS REMOVED AND EXPECTED TO BE RETURNED FOR POST MARKET EVALUATION. NO ADVERSE PATIENT EFFECTS REPORTED AND REPLACEMENT NOTED WITH ANOTHER BSC LEAD MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1