BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6113296 · Received November 18, 2016

    Report

    Report Number
    1723170-2016-02928
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    April 11, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994653482
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY FOR THE NAVIGATION SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE POWER SUPPLY WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND FOUND THE POWER SUPPLY AND P-CLAMP REQUIRED REPLACEMENT. THE MEDTRONIC REPRESENTATIVE REPLACED THE COMPONENTS AND REPORTED THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS RETURNED FULLY FUNCTIONAL. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    RETURN REQUESTED. REPLACEMENT TRANSCEIVER SHIPPED TO SITE 10/24/2016. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT TRANSCEIVER FINDS THAT WHEN TESTED ON A BENCH TESTER, THE DEVICE RAN FOR OVER 48 HOURS WITHOUT ANY COMMUNICATION LOSS. TRIED TO MANIPULATE FIBER ENDS AND DID NOT LOSE CONNECTIVITY. NO FAULT FOUND. DEVICE FOUND TO BE FULLY FUNCTIONAL. 10/25/2016 A MEDTRONIC SR. ELECTRICAL ENGINEER AND SITE SR. TECH PROJECT COORDINATOR POWERED ON THE NAVIGATION SYSTEM AND THE USB PORTS DID NOT WORK, HOWEVER, THE USBVIEW WAS NORMAL. THEY CONFIRMED THE CAMERA COMMUNICATION WAS INTERMITTENT. THEY NOTED THAT A SCREW AND NUT WERE LOOSE AND INSIDE THE NIU POWER SUPPLY. THE NIU FAN WAS NOT WORKING. AFTER RE-WORKING THE NAVIGATION INTERFACE UNIT (NIU) POWER SUPPLY (REMOVED SHORTING SCREW AND NUT) THE NAVIGATION SYSTEM WORKED CONSISTENTLY. SCREW SHORTING COULD HAVE CAUSED A CURRENT LIMIT IN THE 5V POWER SUPPLY WHICH CAUSED LOW TO THE USB PORTS, AXIEM, AND INTERMITTENT FUNCTION TO CAMERA COMMUNICATIONS. REPLACEMENT PARTS WERE SHIPPED TO THE SITE, HOWEVER, ALL WERE RETURNED UNUSED TO MANUFACTURER. 10/28/2016 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, SOFTWARE AND INSTRUMENTS AREAS PASSED. HARDWARE TEST FAILED: AXIEM COMMUNICATION AND OPTICAL COMMUNICATION. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT WHILE IN THE MIDDLE OF A CRANIAL RESECTION PROCEDURE, THEIR; NAVIGATION SYSTEM CAMERA COMMUNICATION STOPPED TRACKING. RED 'X' FOR CAMERA COMMUNICATION AND RED 'X' FOR THE INSTRUMENTS. CAMERA DETAILS WERE "LOCALIZER NOT CONNECTED". THE SITE ATTEMPTED RE-BOOTING THE NAVIGATION SYSTEM THREE TIMES. SITE THEN BURNED A NAVIGATION SYSTEM ARCHIVE FROM THE NAVIGATION SYSTEM BEING USED AND LOADED IT ON A DIFFERENT NAVIGATION SYSTEM TO CONTINUE THE PROCEDURE TO COMPLETION. DELAY IN THERAPY WAS 20-30 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762886 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR