BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NT500 PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7125111 · Received December 18, 2017

    Report

    Report Number
    3002953813-2017-00055
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    December 1, 2017
    Report Date
    January 19, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED TEMPERATURE ISSUE AND IMPEDANCE ISSUE WAS UNABLE TO BE CONFIRMED. FIELD SERVICE TESTING OF THE DEVICE CONFIRMED THAT THE DEVICE FUNCTIONED PROPERLY. THE CAUSE FOR THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED AS THE TEMPERATURE AND IMPEDANCE ISSUES REPORTED WERE NOT REPRODUCED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TEMPERATURE DID NOT INCREASE AND NO IMPEDANCE WAS DISPLAYED. THE PROBE AND GROUNDING PAD WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT WAS UNDER LOCAL ANESTHESIA AND THE PROBE WAS INSERTED. THE PROCEDURE WAS ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904151 NT500 PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other