BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3130366 · Received May 24, 2013

    Report

    Report Number
    1723170-2013-00381
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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

    PATIENT GENDER AND WEIGHT WERE UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE AT THE SITE TO TESTED THE EQUIPMENT AND WAS ABLE TO REPRODUCE THE REPORTED EVENT. THROUGH TROUBLE-SHOOTING AT THE SITE IT WAS DECIDED TO REPLACE THE COMPUTER. THE COMPUTER WAS UPGRADED AND THE SYSTEM CHECK-OUT SHOWED THAT THE DEVICE WAS FULLY FUNCTIONAL. THE RETURNED COMPUTER WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PRODUCT SERVICES PERSONNEL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE SOFTWARE WAS UNRESPONSIVE WHILE ATTEMPTING TO AUTO TRANSFER AN STD. 3D O-ARM SPIN TO THE NAVIGATION SYSTEM. AFTER TROUBLE-SHOOTING, THE SYSTEM WAS RE-BOOTED AND RESUMED PROPER FUNCTION. THEY TOOK ANOTHER STD. 3D SPIN OF THE PATIENT, AND THE IMAGES AUTOMATICALLY TRANSFERRED PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF NAVIGATION. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231633 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR