BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2974883 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00126
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOGS SUGGEST THAT THE TRANSFER OF THE EXAM FROM THE PACS MAY HAVE BEEN PROBLEMATIC, ADDITIONALLY THE LOGS SUGGEST THAT THE APPLICATION ATTEMPTED TO OPEN WHATEVER EVENTUALLY WAS ACQUIRED FROM THE PACS, AND REPORTED THAT VOLUMEOID WAS NOT FOUND, AND THAT THERE WERE INVALID SLICES. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT IN BETWEEN CASES WHEN SELECTING A NEW PATIENT FROM THE LIST IN SYNERGY CRANIAL THE SOFTWARE EXITED TO THE BLUE MEDTRONIC SCREEN. A HARD-BOOT BROUGHT THE SOFTWARE BACK UP AND RUNNING PROPERLY. SINCE THIS EVENT WAS REPORTED IN BETWEEN CASES NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78490 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1