BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2974166 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00111
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 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

    THE USB TREE WAS NOT ABLE TO BE INVESTIGATED TO CONCLUDE ANY OPERATING SYSTEM ROOT CAUSE. NO FURTHER ISSUES HAVE BEEN REPORTED FROM THE SITE.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC ELECTRICAL ENGINEER EVALUATING SEQUENCE OF EVENTS NOTED THAT WHEN THE WIRELESS MOUSE WAS REPLACED WITH A WIRED MOUSE, THE USB TREE MAY HAVE BEEN CORRUPTED CAUSING THE LOSS OF AXIEM COMMUNICATION. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED INTERMITTENT TRACKING WHILE IN A CRANIAL PROCEDURE. INITIALLY A WIRELESS MOUSE WAS REPLACED WITH A WIRED MOUSE. AFTER A SUCCESSFUL REGISTRATION WAS COMPLETED, THE AXIEM BOX IN THE IOR, WITH MACH CRANIAL, GAVE A COMMUNICATION ERROR IN THE SOFTWARE, ERROR CODE (8). A RE-BOOT RE-ESTABLISHED COMMUNICATION AND THE SURGEON PROCEEDED WITH NAVIGATION. THE SURGERY WAS COMPLETED WITH USE OF THE STEALTHSTATION IOR SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78615 STEALTHSTATION IOR SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. IOR

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR