BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 8701240 · Received June 14, 2019

    Report

    Report Number
    1723170-2019-03348
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    June 11, 2019
    Report Date
    June 14, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. UNIQUE DEVICE IDENTIFIER (UDI) IS UNAVAILABLE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE REPORTED ISSUE COULD NOT BE REPLICATED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. DEVICE MANUFACTURE DATE IS UNAVAILABLE. OTHER RELEVANT DEVICE(S) ARE: PN: 9735225R LN: UNK, UDI: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE SETTING UP FOR A PROCEDURE, THE MONITORS OF THE NAVIGATION SYSTEM WERE "FLASHING". THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493856 S7 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1