BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7118999 · Received December 14, 2017

    Report

    Report Number
    3002953813-2017-00053
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 24, 2017
    Report Date
    January 26, 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

    THE REPORTED BOOT UP ISSUE WAS CONFIRMED UPON CONNECTING THE GENERATOR TO AN EXTERNAL POWER SOURCE. THE SYSTEM DID NOT CONTINUE FURTHER AND WAS STUCK ON THE WHITE SCREEN. BASED ON THE PROVIDED INFORMATION AND THE OBSERVED SYMPTOMS WE DETERMINED THAT THE MICROPROCESSOR WAS FAULTY. THE UPPER ASSEMBLY WAS REPLACED AND THE REPORTED EVENT WAS RESOLVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    DURING DEVICE PREPARATION, THE GENERATOR WOULD NOT BOOT UP AND PRESENTED A BLANK SCREEN. THE GENERATOR WAS TURNED OFF AND ON BUT THERE WAS NO RESOLUTION. THE PATIENT WAS ON THE TABLE AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896042 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other