BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3894525 · Received June 25, 2014

    Report

    Report Number
    1723170-2014-00678
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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

    THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND WAS FOUND TO HAVE A MOTHERBOARD FAULT. THE SOFTWARE INVESTIGATION FOUND THAT THE SOFTWARE FUNCTIONED AS DESIGNED, AND CONFIRMED THAT THE ISSUE WAS CAUSED BY A MOTHERBOARD MALFUNCTION. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO REPLACE THE COMPUTER AND TEST THE NAVIGATION EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT AFTER COMPUTER REPLACEMENT.

    Additional Manufacturer Narrative · 1

    NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE ON THE REGISTER SCREEN. MESSAGE DISPLAYED WAS: BOOT AHCI CD ROM. A HARD RE-BOOT OF THE SYSTEM WAS REQUIRED TO RESTORE NORMAL FUNCTION. 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
    371264 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR