BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8665100 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02888
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2017
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733597, SERIAL/LOT #: UNKNOWN, PRODUCT ANALYSIS: MODEL: 9733858; ANALYSIS: CONNECTION FAILURE. 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 DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AXIEM DISPOSABLES WERE NOT SHOWING IN THE SCREEN. THERE WAS A SLIGHT CUT IN THE CABLE. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457938 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1