BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3951303 · Received July 22, 2014

    Report

    Report Number
    1723170-2014-00785
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    March 10, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SEVERAL PROCEDURES HAVE SUBSEQUENTLY BEEN COMPLETED USING THIS NAVIGATION SYSTEM, NO ISSUES HAVE BEEN REPORTED LOADING IMAGES. SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, RESIDENT, REPORTED THAT WHILE IN A CRANIAL RESECTION PROCEDURE, THE 2D IMAGES WERE NOT APPEARING IN THE NAVIGATION SYSTEM. THE DOCTOR CHECKED THE CONTRAST, VERIFIED THE 2D IMAGES WERE SELECTED IN THE EXAM BUTTON AND VERIFIED THERE WERE 2D IMAGES IN THE LOAD PATIENT SCREEN. A SECOND NAVIGATION SYSTEM WAS BROUGHT IN, THE EXAM WAS LOADED, AND THE PATIENT WAS REGISTERED TO CONTINUE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. TROUBLESHOOTING THIS ISSUE CAUSED AN HOUR DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428636 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR