BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7061054 · Received November 27, 2017

    Report

    Report Number
    3002953813-2017-00042
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 27, 2017
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K111576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. THE GENERATOR WAS RECEIVED FOR ANALYSIS AND THE REPORTED EVENT OF A STARTUP FAILURE WAS CONFIRMED. THE GENERATOR WAS CONNECTED TO AN EXTERNAL MONITOR AND A CHECKSUM ERROR APPEARED. THIS BEHAVIOR IS CONSISTENT WITH A DEPLETED CMOS (COMPLEMENTARY METAL-OXIDE SEMICONDUCTOR) BATTERY LOCATED AT THE SYSTEM LEVEL CIRCUIT BOARD. NO ADDITIONAL TESTING WAS PERFORMED AS THE DEVICE WAS RECEIVED IN A CONDITION THAT DOES NOT ALLOW TO COMPLETE A FUNCTIONAL TESTING. THE ROOT CAUSE OF THE STARTUP FAILURE HAS BEEN ISOLATED TO A DEPLETED CMOS BATTERY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE GENERATOR DID NOT STARTUP. POWER CYCLING THE GENERATOR DID NOT PROVIDE RESOLUTION. THE PATIENT WAS SEDATED BEFORE THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838519 4 LESION NT2000¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-2000 6209231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other