BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE TEMPERATURE MONITOR

    MDR report key: 1161371 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04545
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HE LOT NUMBER OF THE DEVICE IS UNK; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT BEEN PERFORMED. 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. A PRODUCT EVALUATION IS PENDING; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    A PROLIEVE RECTAL TEMPERATURE MONITOR (RTM) WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, APPROX THIRTY MINS INTO THE PROCEDURE, THE SYSTEM GAVE A MESSAGE THAT THE RTM WAS MALFUNCTIONING. TWO OF THE THREE SENSORS STOPPED READING AND THE PHYSICIAN ABORTED THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE TEMPERATURE MONITOR MEQ BOSTON SCIENTIFIC CORPORATION M0068808030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK