BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7121578 · Received December 15, 2017

    Report

    Report Number
    3002953813-2017-00050
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 20, 2017
    Report Date
    February 8, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ERROR MESSAGE WAS ABLE TO BE REPRODUCED DURING SIMULATION. A FUSE BLOWN ERROR APPEARED ON THE SCREEN, AND WAS TRACED BACK TO THE RF CONTROL BOARD. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED ERROR MESSAGE WAS DUE TO A FAULTY RF CONTROL BOARD THAT REQUIRED REPLACEMENT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING A CERVICAL ABLATION PROCEDURE, AN ERROR MESSAGE DISPLAYED AND THE PROCEDURE WAS CANCELLED. THREE CERVICAL LESIONS WERE COMPLETED, HOWEVER WHEN THE 4TH LESION WAS ATTEMPTED, A CONTINUOUS ALARM TONE WITH A "FUSE BLOWN" ERROR DISPLAYED ON THE SCREEN. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899835 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 6075342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other