BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 8530959 · Received April 19, 2019

    Report

    Report Number
    3002953813-2019-00026
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 28, 2019
    Report Date
    May 30, 2019
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    UDI-DI
    05415067022370
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE NT 1100 NEUROTHERM RF GENERATOR WAS RECEIVED FOR EVALUATION. AC POWER WAS APPLIED TO THE RF GENERATOR AND THE SYSTEM WAS POWERED ON SUCCESSFULLY. TESTING OF ALL PORTS WAS CONDUCTED WHILE MONITORING THE PORT TEMPS AND IMPEDANCE. AUDIBLE TONES EMITTED WERE CONSISTENT WITH THE MODES OF OPERATION SELECTED. NO HARDWARE ANOMALIES WERE DETECTED IN THIS INVESTIGATION. 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 ABT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    PORTS ONE AND TWO WOULD NOT HEAT TO THE DESIRED TEMPERATURE DURING THE PROCEDURE. THE PROCEDURE WAS CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325579 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100 11081-08 05415067022370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other