BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3771376 · Received April 24, 2014

    Report

    Report Number
    1723170-2014-00413
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    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

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(6). PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE SITE, REPORTED THE ISSUE WAS ABLE TO BE DUPLICATED. HITTING CTRL, ALT AND BACKSPACE KEYS ON KEYBOARD ALLOWED APPLICATION TO CLOSE AND SYSTEM PERFORMED AS EXPECTED AFTER RE-LOADING APPLICATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A SPINAL FUSION PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE. THE SITE PERFORMED TWO SPINS WITH THE IMAGING SYSTEM AND AUTO TRANSFERRED TO THE NAVIGATION SYSTEM. WHILE IN THE SPINE SOFTWARE THE SITE WENT TO CLICK ON THE SECOND OF THE TWO EXAMS AND THE SOFTWARE EXITED BACK TO THE LAUNCH SCREEN. THIS REPORTEDLY HAPPENED A COUPLE OF TIMES. EVENTUALLY WHEN THE SITE SELECTED THE SECOND EXAM AND THE SOFTWARE EXITED, THE SYSTEM BECAME UNRESPONSIVE. THE SITE PERFORMED A SOFT REBOOT TO GET BACK TO THE SOFTWARE LAUNCH SCREEN. THE SITE THEN LAUNCHED SPINE AND MANUALLY PUSHED THE SECOND EXAM FROM THE IMAGING SYSTEM TO THE NAVIGATION SYSTEM. THE EXAM SUCCESSFULLY TRANSFERRED AND THE SITE WAS ABLE TO SELECT IT. AFTER A DELAY OF 15 MINUTES, THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249270 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR