BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THRMODILITATION SYSTEM

    MDR report key: 1181618 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04841
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROLIEVE THERMODILITATION SYSTEM WILL BE SERVICED ON-SITE. THEREFORE, A FAILURE ANALYSIS IS NOT CURRENTLY 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

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILITATION SYSTEM HAD WATER FLOW AND TEMPERATURE ISSUES FOUR DAYS PRIOR. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THRMODILITATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M006880806R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA