BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1230455 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06157
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 10, 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

    THE SERIAL NUMBER PROVIDED BY THE END USER COULD NOT BE CONFIRMED; 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 WAS USED FOR A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE PROLIEVE CONSOLE FAILED TO HEAT UP TO THE PROPER TEMPERATURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M006880806R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK