BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2150815 · Received June 21, 2011

    Report

    Report Number
    1723170-2011-01124
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 29, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A SURGEON CALLED IN REQUESTING HELP ADJUSTING HIS IMAGES WITH A CRANIAL TUMOR RESECTION CASE. A MEDTRONIC REPRESENTATIVE WALKED HIM THROUGH MODIFYING THE LEVEL AND WIDTH WITH THE MOUSE, HOWEVER, HE WAS NOT ABLE TO GET THE IMAGES TO DISPLAY PROPERLY. FURTHER TROUBLESHOOTING WAS HALTED AS THE SURGEON SAID HE WOULD CALL BACK. THE SURGEON THEN REPORTED HE HAD ATTEMPTED A TOUCH-N-GO REGISTRATION AND IT WAS INACCURATE. THE MEDTRONIC REPRESENTATIVE WALKED HIM THROUGH POINTMERGE AND REMOVING THE HEAD HOLDER FROM THE 3D MODEL. HE WAS ABLE TO COMPLETE A SUCCESSFUL POINTMERGE WITH 3.3 MM PREDICTED ACCURACY. HE FOUND THIS ACCEPTABLE AND BEGAN NAVIGATION. THE SURGEON THEN REQUESTED HELP WITH EDITING 2D IMAGES AND SELECTING PROJECTION. THE SURGEON CONTINUED THE CASE USING THE STEALTHSTATION S7. 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 67 YR