BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 3131778 · Received May 29, 2013

    Report

    Report Number
    1723170-2013-00382
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE MANUFACTURING DATE IS UNAVAILABLE AT THE TIME OF THIS REPORT. THE MEDTRONIC REPRESENTATIVE, AT THE SITE, INSTRUCTED THE SITE ON ARCHIVING CORE FILES ONTO A CD TO SEND IN. ALSO, TESTED THE GRAPHICS CARD IN UNIX, AND THE SYSTEM PERFORMED AS EXPECTED. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE STEALTHSTATION TREON RAN NORMALLY THROUGHOUT THE PROCEDURE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN EXAM WAS LOADED USING MACH CRANIAL 5.2.5., THEN WHEN GOING BACK TO THE PREP PHASE, THE SOFTWARE UNEXPECTEDLY EXITED TO THE APPLICATION SCREEN. THE SOFTWARE WAS RE-ENTERED AND PERFORMED PROPERLY. THE MEDTRONIC REPRESENTATIVE TESTED THE GRAPHICS CARD IN UNIX, PERFORMED AS EXPECTED. THIS OCCURRED PRIOR TO A PROCEDURE, THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237032 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TREON

    Patients

    Seq Age Sex Outcome Treatment
    1