BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4953366 · Received July 30, 2015

    Report

    Report Number
    1723170-2015-00941
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 29, 2015
    Report Date
    February 17, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    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

    (B)(4). SOFTWARE INVESTIGATION COMPLETED. SYSTEM SOFTWARE LOG ANALYSIS FOUND THE LOGS DID NOT CONTAIN ANYTHING THAT SPECIFICALLY INDICATED WHY THE SYSTEM UNEXPECTEDLY EXITED. THIS ISSUE WILL BE CONTINUALLY MONITORED AND TRENDED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE ON (B)(4) 2015, THAT WHILE IN A CRANIAL PROCEDURE ON (B)(6) 2015, THE SITE STAFF SELECTED THE QUERY RETRIEVE (Q/R) BUTTON IN CRANIAL AND THE SOFTWARE UNEXPECTEDLY EXITED TO THE LOGO SCREEN. AFTER A FEW SECONDS, THE NAVIGATION SYSTEM RE-BOOTED ITSELF AND RETURNED TO THE LAUNCH SCREEN. THE SURGEON CONTINUED, AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. NOTED WAS THAT THE NAVIGATION SYSTEM FUNCTIONED NORMALLY IN SUBSEQUENT SURGERIES PERFORMED ON THE SAME AFTERNOON, (B)(6) 2015, AND THE FOLLOWING DAY, (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497681 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR