BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1133519 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03767
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE USING A PROLIEVE THERMODILITATION SYSTEM FOR BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE WATER TEMPERATURE GRADUALLY INCREASED PAST THE 35 DEGREE POINT. THE COMPLAINANT STATES THAT THEY HAVE TO DO ADD'L SET POINT ADJUSTMENTS TO KEEP THE WATER TEMPERATURE WITHIN SPECS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE AND NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M006880806RO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK