BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2050093 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00562
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT PRESENT. THIS ISSUE WAS RESOLVED BY ADVISING THE RADIOLOGY DEPARTMENT AT THE USER FACILITY TO REDUCE THE NUMBER OF THE SLICES ARCHIVED IN THE EXAM SERIES. THE LATEST SOFTWARE UPGRADE VERSION NOW SUPPORTS THE USE OF EXAMS WITH MORE SLICES.

    Description of Event or Problem · 1

    SITE REPORTED THAT USING SPINE 1.7 HAS RESULTED IN THE SOFTWARE CRASHING AT VARIOUS TASKS IN THE SOFTWARE INCLUDING LOADING THE EXAM AND SELECTING PROCEDURE TYPE. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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