BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1133506 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03729
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 PROLIEVE THERMODILITATION SYSTEM WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE A DAY PRIOR. ACCORDING TO THE COMPLAINANT, FIVE MINUTES INTO THE PROCEDURE, THE SCREEN GOES BLACK, DISPLAYS "NO INPUT", AND THEN REBOOTS ITSELF. AFTER THE REBOOT, THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PATIENT 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 M006880806R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR