BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURONAV

    MDR report key: 4567509 · Received February 10, 2015

    Report

    Report Number
    9615126-2015-00001
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    January 14, 2015
    Report Date
    February 10, 2015
    Manufacturer
    ALPHA OMEGA ENGINEERING LTD.
    Product Code
    GZL
    PMA / PMN Number
    K071697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING INVESTIGATION, SIMULATION OF THE MALFUNCTION AND FINDING THE EXACT CAUSE, OUR CONCLUSION IS THAT THE DESIGNED MITIGATIONS TO PREVENT UNCONTROLLED MOVEMENT OF THE NEURONAV DRIVE UNIT ARE EFFECTIVE. NEVERTHELESS, SINCE THE SYSTEM DETECTS THE POTENTIAL MALFUNCTION AND ISSUES, AN ERROR MESSAGE ON THE NEURONAV SCREEN, WE SHALL IMMEDIATELY NOTIFY OUR CUSTOMERS TO MOVE ELECTRODE MANUALLY, ONCE THE ERROR MESSAGE APPEARS AND REFRAIN FROM USING THE SOFTWARE CONTROLLED MOVEMENT.

    Description of Event or Problem · 1

    DURING A DBS IMPLANTATION NEUROSURGERY, THE NEUROSURGEON MOVED THE NEUROELECTRODE BY PRESSING THE REMOTE CONTROL "IN" KEY. NORMALLY THE MOVEMENT STOPS AFTER 1MM, INSTEAD IT WAS NOTICED THAT MOVEMENT SPEED IS HIGH AND THE MOVEMENT STOPPED AFTER 5 MM, ADDITIONALLY, THE DEPTH WAS NOT DISPLAYED ON THE NEURONAV SCREEN (AS SUPPOSED TO). THE NEUROSURGEON THEN DECIDED TO CONTINUE THE NEUROSURGERY BY USING THE MANUAL ELECTRODE MOVING OPTION AND THE DBS ELECTRODE WAS SUCCESSFULLY IMPLANTED. THE PROBLEM WAS FOUND TO BE A FAULTY CABLE BETWEEN THE NEURONAV AND THE NEURONAV DRIVE UNIT. REPLACING THE CABLE SOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98089 NEURONAV MICROELECTRODE RECORDING AND STIMULATION SYSTEM GZL ALPHA OMEGA ENGINEERING LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention