BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 12555649 · Received September 30, 2021

    Report

    Report Number
    1723170-2021-02399
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 24, 2021
    Report Date
    September 30, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00763000272739
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9734252, SERIAL/LOT #: 190315; PRODUCT ID: 9734252, SERIAL/LOT #: 150820; PRODUCT ID: 9734252, SERIAL/LOT #: 160331. NO PARTS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. 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. IT WAS REPORTED THAT THE SITE REGISTERED THE PATIENT AND GOT A METRIC OF 0.6 MM. AFTER THE SITE WENT STERILE THEY WERE OFF A FEW INCHES AND ABORTED USE OF NAVIGATION. AFTER THE CASE IT WAS DETERMINED THAT THE VERTEK ARM COULD NOT FULLY TIGHTEN. A MANUFACTURING REPRESENTATIVE (REP) CHECKED ALL VERTEK ARMS ON SITE AND A TOTAL OF 3 ARMS WOULD NOT FULLY LOCK. ARM MOVEMENT WAS CONFIRMED BY THE MANUFACTURING REPRESENTATIVE (REP). THE PROCEDURE WAS DELAYED BY LESS THAN ONE HOUR AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450849 STEALTHSTATION S8 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9735665 00763000272739

    Patients

    Seq Age Sex Outcome Treatment
    1