BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3150839 · Received June 6, 2013

    Report

    Report Number
    1723170-2013-00409
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT PRESENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF PHYSICAL DAMAGE. ALL THE COLOR HAD FADED FROM THE ARTICULATING ARM. THERE WERE MANY NICKS AND SCRATCHES ON THE DEVICE. THE HANDLE WAS LOCKED UP WITH THE JOINTS IN A LOOSE STATE. IT WAS NOT POSSIBLE TO LOCK DOWN THE ARTICULATING ARM AND THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE ARTICULATING ARM WAS NO LONGER LOCKING DOWN TIGHTLY. HE THOUGHT IT WAS JUST A RESULT OF USE OVER TIME. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251004 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1