BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3173600 · Received June 17, 2013

    Report

    Report Number
    1723170-2013-00442
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    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

    MEDTRONIC REPRESENTATIVE, AT THE SITE, NOTED THAT WHILE ARCHIVING, FOUND THAT OUTSIDE THE OPERATING ROOM, THE MOUSE WAS UNRESPONSIVE. THE TOUCH-SCREEN IN THE ROOM AND THE TOUCH-PAD ON THE RACK WORKED WITHOUT ISSUE. UNPLUGGED THE MOUSE OUTSIDE THE ROOM, REPLUGGED IT, AND IT WORKED PROPERLY. SOFTWARE EVALUATION AS NOT BEEN COMPLETED TO DATE.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE LOGFILE WAS CORRUPTED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED AND THE BEHAVIOR COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE USING SYNERGY CRANIAL SOFTWARE, THE SYSTEM BECAME UNRESPONSIVE DURING THE NAVIGATION TASK. THE SITE REPRESENTATIVE, TECHNICAL COORDINATOR, PERFORMED A RE-BOOT OF THE SYSTEM TO RESTORE IT TO NORMAL FUNCTIONALITY. 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
    273111 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR