BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION SYSTEM

    MDR report key: 1191227 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04920
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 THERMODILATATION SYSTEM WAS BEING SERVICED ON-SITE THE DAY PRIOR. THE FIELD SERVICE ENGINEER REPORTED THE DEVICE HAD NO FORWARD OR RELECTED POWER, AND A LOUD SNAP WAS HEARD ACCOMPANIED BY SMOKE. THE SUSPECTED PROBLEM IS WITH THE RF BOARD, ALTHOUGH THIS INFORMATION HAS NOT BEEN CONFIRMED. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M006880800DO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA