BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7080454 · Received December 4, 2017

    Report

    Report Number
    3002953813-2017-00048
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 8, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED TEMPERATURE ISSUE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED TEMPERATURE ISSUE AND SUBSEQUENT PROCEDURE CANCELLATION COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PROBE WAS NOT HEATING TO TEMPERATURE. THE GENERATOR WAS RECONNECTED AND THE PROBE WAS REPLACED BUT THERE WAS NO RESOLUTION. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859641 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100 9801364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other