BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2181445 · Received July 5, 2011

    Report

    Report Number
    1723170-2011-01189
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO IS UNAVAILABLE FROM THE SITE AT THE TIME OF THIS REPORT. SITE REP RE-INSTALLED THE SOFTWARE WITH NO INSTALLATION ISSUES / ERRORS. THE PROBLEM PERSISTED. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT WHEN THE SURGEON BROUGHT THE BIOPSY NEEDLE UP TO THE VERTEK PROBE, THE SYSTEM BOOTED HIM OUT TO THE LOG-IN SCREEN SEVERAL TIMES. THE SURGEON DISCONTINUED USE OF THE STEALTHSTATION S7 TO COMPLETE THE CRANIAL SURGERY. NO IMPACT ON PT'S OUTCOME WAS 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