BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3103181 · Received May 9, 2013

    Report

    Report Number
    1723170-2013-00330
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN.THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION OF RETURNED DEVICE FOUND THAT WHEN THE HANDLE WAS TIGHTENED, NEITHER END OF THE VERTEK ARM WAS LOCKED DOWN. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT AN ARTICULATING ARM WILL NOT TIGHTEN DOWN PROPERLY, ALLOWING POSSIBLE MOVEMENT OF THE REFERENCE FRAME. THIS CONCERN WAS NOT IDENTIFIED DURING A PROCEDURE, THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203381 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1