BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3234034 · Received July 18, 2013

    Report

    Report Number
    1723170-2013-00530
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION PROVIDED.(B)(4).

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM SITE AT TIME OF THIS REPORT. MEDTRONIC REPRESENTATIVE FOLLOWING UP AT THE SITE PERFORMED A SYSTEM CHECK-OUT AND THE NAVIGATION SYSTEM WORKED PROPERLY. SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE THE PREVIOUS DAY, THE NAVIGATION SYSTEM EXITED UNEXPECTEDLY DURING NAVIGATION. THE MONITOR WENT TO A BLACK SCREEN AND A RE-BOOT WAS REQUIRED TO RETURN THE SYSTEM TO NORMAL FUNCTION. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333417 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Congenital Anomaly