BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7122621 · Received December 15, 2017

    Report

    Report Number
    3002953813-2017-00054
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 29, 2017
    Report Date
    January 30, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TEMPERATURE ISSUE WAS CONFIRMED. DURING SIMULATION TESTING THE TEMPERATURE ISSUE WAS REPRODUCED AND THE TEMPERATURE SHOWN ON THE SCREEN WAS OVER THE LIMIT. BASED ON THE PROVIDED INFORMATION AND THE OBSERVED SYMPTOMS WE DETERMINED THAT THE TEMPERATURE BOARD WAS FAULTY. THE TEMPERATURE BOARD WAS REPLACED AND THE REPORTED EVENT WAS RESOLVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING A PULSED RADIO FREQUENCY PROCEDURE, ALL THE PORTS ON THE GENERATOR EXPERIENCED AN INCREASE ABOVE 42 DEGREE CELSIUS IN TEMPERATURE. THE PATIENT WAS PREPPED AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900517 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 9800229

    Patients

    Seq Age Sex Outcome Treatment
    1 Other