BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 9806660 · Received March 9, 2020

    Report

    Report Number
    1723170-2020-00803
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 9, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994665928
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735346R, SERIAL/LOT #: (B)(4), UDI#: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE ISSUE COULD NOT BE CONFIRMED OR REPLICATED, NO COMPONENTS WERE REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE LOCALIZER WAS DISCONNECTED. THE LOCALIZER WAS WORKING AND THEN THE SITE TOOK AN IMRI WITH "IMRIS" AND MERGED IT WITH THE SCAN IN THE SOFTWARE. THE MANUFACTURER REPRESENTATIVE REBOOTED THE SYSTEM AND THE NETWORK INTERFACE UNIT (NIU) IN THE ROOM, BUT THIS DID NOT RESOLVE THE ISSUE. AT THIS POINT THE SURGEON HAD RESECTED ENOUGH TUMOR THAT HE WAS COMFORTABLE ABORTING NAVIGATION AND PROCEEDING WITH THE CASE. THERE WAS NO KNOWN IMPACT ON THE PATIENT. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR DUE TO THIS ISSUE. IT WAS CONFIRMED THAT THE SYSTEM IS FUNCTIONING AS INTENDED AFTER PRESSING THE RESET BUTTON ON THE BACK OF THE NIU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269773 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734062 00613994665928

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR