BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2893629 · Received January 2, 2013

    Report

    Report Number
    1723170-2012-00703
    Event Type
    Other
    Date Received
    January 2, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING MEDTRONIC REPRESENTATIVE STATED THE PATIENT WEIGHT IS NOT AVAILABLE FROM THE SITE. FILED HAVE NOT YET BEEN REC'D BY MANUFACTURER FOR INVESTIGATION. SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL SHUNT CASE, THE CAMERA LOST COMMUNICATION AND DISPLAYED A RED X ON THE CAMERA ICON, AT THE BOTTOM. THE OPERATING ROOM STAFF RE-BOOTED THE SYSTEM, IT THEN FUNCTIONED PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT TO THE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female