BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7080846 · Received December 4, 2017

    Report

    Report Number
    3002953813-2017-00047
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 7, 2017
    Report Date
    March 4, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. THE NEUROTHERM GENERATOR WAS CONNECTED TO AN EXTERNAL POWER SOURCE AND POWERED ON SUCCESSFULLY. DURING LESION SIMULATION, THERE WERE UNSTABLE IMPEDANCE LEVELS AND VOLTAGE DROPS WHICH WAS ISOLATED TO A FAULTY UPPER ASSEMBLY. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED EVENT WAS DUE TO FAULTY UPPER ASSEMBLY. 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.

    Description of Event or Problem · 1

    DURING A GASSERIAN GANGLIOLYSIS PROCEDURE, THERE WERE IMPEDANCE ISSUES WITH THE GENERATOR AND THE PROCEDURE WAS CANCELLED. DURING SENSORY STIMULATION, THE IMPEDANCE READING WAS "O/C". THE CONNECTIONS WERE CHECKED AND THE GENERATOR WAS RESTARTED BUT THE IMPEDANCE READ 1000 OHMS AND QUICKLY CHANGED TO "O/C". ADDITIONAL TROUBLESHOOTING WAS PERFORMED BUT THE IMPEDANCE FLUCTUATED BETWEEN 200-400 OHMS, SO THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859207 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other