BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2582707 · Received May 17, 2012

    Report

    Report Number
    1723170-2012-00236
    Event Type
    Malfunction
    Date Received
    May 17, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    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

    Additional Manufacturer Narrative · 1

    THE PT WEIGHT IS NOT AVAILABLE FROM THE SITE. THE SITE HAD OVER 30 PTS LOADED ON THE SYSTEM. IT WAS SUGGESTED THAT THEY REMOVE OLD PT EXAMS FROM THE SYSTEM. THE MFR IS UNABLE TO DETERMINE THE ROOT CAUSE SINCE THE LOGS PROVIDED DID NOT PROVIDE ANY CONCLUSIVE INFO.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SOFTWARE UNEXPECTEDLY EXITED TO THE LOGIN SCREEN FROM THE "FRAME SETTINGS" SCREEN. WHEN THEY CAME BACK INTO THE SOFTWARE, THE PLANNING THAT THEY HAD DONE HAD NOT BEEN SAVED. THEY WERE NOT USING THE SOFTWARE AT THE TIME AND HAD ALREADY COMPLETED THE LEFT SIDE OF THE DBS CASE AND WERE WORKING ON THE RIGHT SIDE. THEY HAD THE FRAME SETTINGS WRITTEN DOWN AND THERE WAS NO IMPACT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR