BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081208 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00813
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 4, 2010
    Report Date
    March 4, 2010
    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

    SITE SENT IN EXAMS, BUT ENGINEERS WERE NOT ABLE TO LOAD THEM ON THE STEALTH. THIS ISSUE OCCURRED ONLY ONE TIME. MEDIA_IO VERSION USED AT SITE HAS BEEN UPGRADED. THIS ISSUE WAS NOT REPRODUCIBLE IN-HOUSE, NO FURTHER INVESTIGATION AS NO OTHER EXAMS SENT IN.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THE SITE IS EXPERIENCING ISSUES, WHEN LOADING MULTIPLE EXAMS FROM THE SAME PT. THEY LOAD ONE EXAM AND PERFORM A PROCEDURE. THEN LOAD A SECOND EXAM AT A LATER DATE, WHICH HAS THE SAME PT NAME, AND IT AUTOMATICALLY GETS COMBINED WITH THE ORIGINAL EXAM. WHEN THEY SELECT THE MOST RECENT EXAM, THE 2D IMAGES ARE CORRECT BUT THE 3D MODEL AND REGISTRATION FROM THE ORIGINAL EXAM ARE THERE. NO IMPACT ON PT OUTCOME REPORTED.

    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 UNK