BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 9214524 · Received October 21, 2019

    Report

    Report Number
    1723170-2019-05301
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 24, 2019
    Report Date
    December 24, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE AT THE TIME OF FILING. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733575, SERIAL/LOT #: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE SCU TO PSU CABLE WAS REPLACED AND THE SYSTEM THEN PASSED A SYSTEM CHECKOUT. THE CABLE WAS RETURNED TO MEDTRONIC FOR ANALYSIS AND THE RIGHT ANGLE LEMO CONNECTOR AND PINS WERE FOUND TO BE DAMAGED. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION) PATIENT INFORMATION PROVIDED. CORRECTION: INITIAL REPORTER UPDATED. 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 DURING A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WOULD STOP COMMUNICATING WITH THE SYSTEM, INTERMITTENTLY DISPLAYING "LOCALIZER NOT CONNECTED". A MANUFACTURING REPRESENTATIVE CHECKED THE NDI TOOLBOX AFTER THE PROCEDURE AND THERE WERE NO ERRORS ON EITHER THE POWER SUPPLY UNIT (PSU) OR SYSTEM CONTROL UNIT (SCU). THERE WAS NO DELAY TO THE PROCEDURE AS A RESULT OF THIS ISSUE AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THIS WAS A TUMOR RESECTION PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO IMPACT TO PATIENT OUTCOME. THE ISSUE WAS INTERMITTENT SO THE CASE WAS COMPLETED NORMALLY JUST WITH THE ISSUE OCCURRING PERIODICALLY THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009962 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR