BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 7125552 · Received December 18, 2017

    Report

    Report Number
    1723170-2017-05186
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 21, 2017
    Report Date
    February 14, 2018
    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 SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND ASKED ABOUT THE BOOT UP SEQUENCE. REPRESENTATIVE REPORTED THAT THE SITE LEFT THE RACK POWERED ON ALL NIGHT AND THE NAVIGATION INTERFACE UNIT (NIU) WAS TURNED OFF UNTIL THE BEGINNING OF THE CASE. MEDTRONIC REPRESENTATIVE INFORMED SITE TO TURN OFF BOTH RACK AND NAVIGATION INTERFACE UNIT (NIU) AFTER CASES. SYSTEM HAS BEEN WORKING NORMALLY AFTER REBOOT. NO PARTS WERE REPLACED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING CRANIAL RESECTION, WHILE SETTING UP THE PATIENT FOR REGISTRATION, THE NAVIGATION SYSTEM DISPLAYED A "LOCALIZER NOT CONNECTED" MESSAGE. WHEN TRYING TO MOVE BACK OUT OF SOFTWARE, THE SYSTEM BECAME UNRESPONSIVE. A HARD SHUTDOWN WAS PERFORMED ON NAVIGATION INTERFACE UNIT (NIU) AND THE RACK AND UPON TURNING BACK ON, THE SYSTEM WAS FUNCTIONING NORMALLY. SITE PROCEEDED WITH CASE. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904911 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7 00613994653482

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR