BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7142600 · Received December 22, 2017

    Report

    Report Number
    3002953813-2017-00057
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 22, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED CANCELLATION COULD NOT BE CONFIRMED. THE ROOT CAUSE CANNOT CONCLUSIVELY BE DETERMINED AS THE REPORTED EVENT WAS NOT REPRODUCIBLE AND THE GENERATOR OPERATED AS INTENDED DURING ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE THE PATIENT WAS NOT RESPONDING TO THE TEST STIMULATION. THE TEMPERATURE WAS RISING ON THE GENERATOR BUT THERE WAS NO RESPONSE FROM THE PATIENT. PROBES WERE EXCHANGED BUT THERE WAS NO RESOLUTION AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922925 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 9801366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other