BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1200113 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05286
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE PROLIEVE THERMODILITATION SYSTEM WILL BE SERVICED ON-SITE. THEREFORE, A FAILURE ANALYSIS IS NOT CURRENTLY AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION SYSTEM HAD TEMPERATURE ISSUES SIX DAYS PRIOR. THERE WAS NO PROCEDURE OR PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M00688080R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK