BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2920385 · Received January 17, 2013

    Report

    Report Number
    1723170-2013-00038
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND FOUND THAT A POWER SWITCH INSIDE THE SYSTEM HAD BEEN FLIPPED TO THE OFF POSITION BY CORD, AFTER FLIPPING THE SWITCH BACK TO THE ON POSITION, THE SYSTEM IS PERFORMING PROPERLY. NO PARTS REPLACED OR SENT BACK TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE STEALTHSTATION S7'S CAMERA INTERMITTENTLY GOES TO BLACK STATUS, AND DOES NOT HAVE ANY LIGHTS ON TO INDICATE IT IS RECEIVING POWER. WHEN THEY MOVE THE S7 CAMERA ARM, IT INCREASES THE INTERMITTENT BEHAVIOR. THIS WAS NOT REPORTED DURING A CASE AND NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26788 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1