BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3951005 · Received July 22, 2014

    Report

    Report Number
    1723170-2014-00793
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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

    ENGINEERING REVIEW OF THE SYSTEM ERROR LOGS FOUND MULTIPLE I/O HUB ERRORS. A REPLACEMENT I/O HUB HAS BEEN SENT TO THE SITE FOR ISSUE RESOLUTION. NO FURTHER SUBSEQUENT ISSUES HAVE OCCURRED POST COMPUTER REPLACEMENT.

    Additional Manufacturer Narrative · 1

    THE I/O HUB WAS REPLACED ON THE SYSTEM. SYSTEM TESTED FULLY FUNCTIONAL AFTER REPLACEMENT OF I/O HUB. THE SUSPECT SYSTEM I/O HUB WAS RETURNED AND EVALUATED. NO FAULT WAS FOUND. THE UNIT TESTED FULLY FUNCTIONAL ON ALL PORTS. AFTER REPLACEMENT OF THE I/O HUB AND THE COMPUTER NO FURTHER RELATED SUBSEQUENT ISSUES HAVE RECURRED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT WITHOUT RE-BOOTING THER SYSTEM, AND USING THE ORIGINAL SURGEON PROFILE/PROCEDURE, COULD NOT DUPLICATE ANY FREEZE OR PERFORMANCE ISSUES IN TESTING WITH THE RESIN HEAD MODEL. ALL REGISTRATION MODALITIES WORKED AND NO UNRESPONSIVE EVENTS. PER THE SURGICAL TECH, IN THE PROCEDURE, IN THE REPORTED PROCEDURE, THEY REGISTERED THE PATIENT USING TOUCH-N-GO AND WERE NOT SATISFIED WITH THE ACCURACY NUMBER. SWITCHING TO POINTMERGE, THE I7 OR TOUCH SCREEN DID NOT RESPOND, NOR DID THE WIRELESS MOUSE; IN THE SERVER, THE MOUSE WAS ALSO UNRESPONSIVE. A HARD SHUT-DOWN OF THE SYSTEM, AND A RE-BOOT, RESTORED FUNCTION, THE PATIENT WAS SUCCESSFULLY REGISTERED WITH POINTMERGE, AND THE PROCEDURE CONTINUED TO COMPLETION WITH NO FURTHER ISSUES. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS RETURNED TO MANUFACTURER FOR EVALUATION. INITIAL TESTING FOUND NO HARD DRIVE OR RAM ERRORS. THE LOGS WERE REVIEWED BY SOFTWARE ENGINEERING AND THERE WERE MULTIPLE INPUT/OUTPUT HUB ERRORS IDENTIFIED INDICATING A POTENTIAL ISSUE WITH THE I/O HUB. THE COMPUTER WAS REPLACED AT THE SITE AND A SYSTEM CHECKOUT SHOWED THAT THE SYSTEM WAS FULLY FUNCTIONAL. A MEDTRONIC REPRESENTATIVE REPORTED THAT SEVERAL SUBSEQUENT CASES WERE COMPLETED SUCCESSFULLY USING THE SYSTEM.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SYNERGY CRANIAL PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE DURING TOUCH-N-GO REGISTRATION. THE SYSTEM WAS RE-BOOTED AND NORMAL FUNCTION WAS RESTORED. 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
    427867 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR