BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2062205 · Received April 12, 2011

    Report

    Report Number
    1723170-2011-00772
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT DURING A CRANIAL SURGERY, THE SYNERGY CRANIAL APPLICATION EXITED WHILE ADJUSTING "VIEW SETTINGS" IN NAVIGATE. THE SOFTWARE EXITED A SECOND TIME WHILE TRYING TO CYCLE VIEWS. DURING THE SECOND INVOLUNTARY APPLICATION EXIT, RECEIVED AN ERROR MESSAGE SAYING, "EM INTERFACE ERROR". PROCEDURE WAS AN OPTICAL BIOPSY. SYSTEM WAS RESTARTED BOTH TIMES AND THE CASE WAS ABLE TO PROCEED WITH NAVIGATION. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR