BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7002742 · Received November 6, 2017

    Report

    Report Number
    3002953813-2017-00034
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    June 7, 2017
    Report Date
    November 6, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE REPORTED SHUT DOWN AT THE BEGINNING OF THE PROCEDURE AND SUBSEQUENT CANCELLATION WAS DUE TO A FAULTY UPPER ASSEMBLY. THE DEVICE FUNCTIONED AS INTENDED FOLLOWING REPAIR. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782132 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 2017-10

    Patients

    Seq Age Sex Outcome Treatment
    1