BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1324397 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02147
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    March 17, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT . SENSOR PROBLEMS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY. THE EVALUATION OF THIS DEVICE FOUND THE CHANNEL 1 TC MODULE WAS NOT SEATED PROPERLY CAUSING A "0" READING. THE MODULE WAS RE-SEATED AND TC 1 READS PROPERLY. THE REPORTED PROBLEM WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ON MARCH 19, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROLIEVE THERMODILIATION SYSTEM WAS USED TWO DAYS PRIOR, IN A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE (PATIENT WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE PERFORMING ABLATION, THE RECTAL TEMPERATURE MONITOR (RTM) TEMPERATURE SENSOR NUMBER ONE FAILED. THE RTM WAS REPLACED AND THE RTM SENSOR NUMBER ONE FAILED AGAIN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 MEQ BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M006880800D0

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR