BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 9918061 · Received April 2, 2020

    Report

    Report Number
    3002953813-2020-00015
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 16, 2020
    Report Date
    May 26, 2020
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    UDI-DI
    05415067022417
    PMA / PMN Number
    K111576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: H6. ADDITIONAL INFORMATION: G4, G7, H2.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G4, G7, H2, H3, H4, H6. ONE NT 2000 NEUROTHERM RF GENERATOR WAS RECEIVED. THE GENERATOR WAS CONNECTED TO AN EXTERNAL POWER SOURCE AND THE GENERATOR POWERED ON SUCCESSFULLY. THE REPORTED UNCOMMANDED RF DELIVERY WAS ABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE PROVIDED INFORMATION AND THE OBSERVED SYMPTOMS, THE ISSUE WAS ISOLATED TO AN ABNORMAL FUNCTIONING OF THE THIRD RF AMPLIFIER BOARD. RE-CALIBRATION OF THE RF AMPLIFIER BOARD RESOLVED THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE RF GENERATOR RELEASED RF THERAPY WITHOUT BEING SELECTED. AFTER PLACING THE PROBE IN THE TREATMENT LOCATION, THE USER CHANGED THE GENERATOR SETTINGS FROM SENSORY TESTING TO PULSED RF. RF ENERGY WAS DELIVERED, HOWEVER; THE PATIENT WAS STARTLED AS THE RF WAS NOT EXPECTED. THE PROBE WAS DISCONNECTED FROM THE GENERATOR AND THE GENERATOR WAS STOPPED WHEN THIS OCCURRED TO PREVENT ANY FURTHER DELIVERY OF RF ENERGY. AN ERROR MESSAGE WAS DISPLAYED AT THIS TIME AS WELL. THE PATIENT REMAINED STABLE THROUGHOUT THE DURATION OF THE PROCEDURE AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382061 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 9800229 05415067022417

    Patients

    Seq Age Sex Outcome Treatment
    1