BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2061548 · Received March 16, 2011

    Report

    Report Number
    1723170-2011-00667
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE PER THE INITIAL REPORTER. WHEN CONNECTED TO KNOWN GOOD SYSTEM, THE I/O HUB AND POWER SUPPLY PERFORMED AS EXPECTED. IN AN EXTENDED RUN THE SYSTEM DID NOT CYCLE OR DISPLAY THE REPORTED BLACK STATUS ISSUE. NO PROBLEM FOUND WITH THE RETURNED DEVICES. THE PARTS WERE REPLACED AND THE SYSTEM CHECKOUT SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED NO POWER TO SURGEON MONITOR AND INSTRUMENTS DISPLAYING DISCONNECTED. THE SITE BROUGHT IN AN ADDITIONAL STEALTHSTATION S7 FOR THE CASE. THE PATIENT WAS ON THE TABLE BUT THEY HAD THE OTHER SYSTEM UP AND RUNNING PRIOR TO THE SURGEON NEEDING THE STEALTH. THE PROCEDURE CONTINUED AS PLANNED, WITH NO DELAY TO THE CASE. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1