BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROTHERM RFA MACHINE

    MDR report key: 3978995 · Received July 23, 2014

    Report

    Report Number
    3978995
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    NEUROTHERM INC
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BOTH MACHINES KEPT MALFUNCTIONING DURING THE PROCEDURE. FIRST THE OLD NEUROTHERM MACHINE WHICH WAS SWITCHED TO THE NEW NEUROTHERM MACHINE. BOTH WOULD NOT WORK. BOTH LOCATED IN STERILE CORE OF MOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432238 NEUROTHERM RFA MACHINE GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM INC NT2000 *
    432239 NEUROTHERM RFA MACHINE GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM INC NT2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR