BEUDAMED
    FDA Adverse Event Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3233448 · Received July 18, 2013

    Report

    Report Number
    1723170-2013-00525
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 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

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN UNEXPECTED SOFTWARE EXIT FROM SYNERGY CRANIAL S7. THE NAVIGATION SYSTEM HAD BEEN LEFT ON AT THE NAVIGATE SCREEN OVERNIGHT. THE MEDTRONIC REPRESENTATIVE DID A RE-BOOT AND THE SYSTEM FUNCTIONED AS EXPECTED. THERE WAS NO PATIENT PRESENT AS THIS OCCURRED OUTSIDE OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334177 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1