BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4201019 · Received October 27, 2014

    Report

    Report Number
    1723170-2014-01127
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOW PROVIDED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. (B)(4) 2014. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. THE NAVIGATION SYSTEM WAS SHUT-DOWN/RE-STARTED MULTIPLE TIMES; LAUNCHED ENT APPLICATION AND PERFORMED A REGISTRATION; LAUNCHED THE CRANIAL APPLICATION AND PERFORMED BOTH A POINTMERGE AND TOUCH-N-GO REGISTRATION. SYSTEM PERFORMED AS INTENDED. REPORTED ISSUE COULD NOT BE REPLICATED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE SETTING-UP FOR A CRANIAL PROCEDURE, THE NAVIGATION SYSTEM BECAME INTERMITTENTLY UNRESPONSIVE ON BOOT-UP, THE MONITOR SCREEN WENT BLACK. THE MOUSE WAS ALSO UNRESPONSIVE AFTER REGISTRATION. A RE-BOOT OF THE SYSTEM RETURNED TO THE NAVIGATE SCREEN AND RESTORED 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
    681740 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR