BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1171419 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04641
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 18, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS IS NOT 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

    ON AUG 18, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PROLIEVE SYSTEM RECEIVED ERROR MESSAGES STATING "WATER PRESSURE IS TOO LOW AND WATER LEVEL IS TOO LOW." THERE IS NO FURTHER INFO AVAILABLE REGARDING THE PROCEDURE. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK