BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 NAVIGATION

    MDR report key: 10410948 · Received August 14, 2020

    Report

    Report Number
    1723170-2020-02176
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 9733597, SERIAL/LOT #: 180308. A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EVALUATE THE EQUIPMENT. HARDWARE PARTS WERE REPLACED, AND THE SYSTEM PASSED CHECKOUT. THE RETURNED CABLE JACKET WAS ANALYZED. IT WAS FOUND THAT IT HAD SEPARATED ON THE RETURNED CABLE NEAR THE LEMO CONNECTOR EXPOSING THE SHIELD WIRE WHICH HAS BEEN SEVERED. A CONTINUITY TEST REVEALED OPENS AT PINS 1 AND 4 OF THE USB CABLE. 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 BEING USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH THE BREAK-OUT BOX COMMUNICATION WITH THE SYSTEM. THE BOX WAS NOTED TO HAVE AN 8 WHEN THE SITE TOOK A LOOK AND WAS TROUBLESHOOTING THE SYSTEM. THE SITE WAS ABLE TO SWAP THE BOX OUT FOR ANOTHER BOX AND THE SYSTEM WASN'T ABLE TO COMMUNICATE AND WAS STILL SHOWING AN 8. WHEN THE SITE SWAPPED OUT THE CABLE, THEY WERE ABLE TO ESTABLISH A CONNECTION AND PROCEED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871130 STEALTHSTATION S7 NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1