BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081200 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00834
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC REP STATED THE ISSUE WITH ACQUIRING A SECOND IMAGE IS STILL PERSISTING. INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    SITE REPORTED THAT THEY WERE UNABLE TO ACQUIRE A LATERAL IMAGE IN THE FLUORONAV APPLICATION WITH THE S7 SYSTEM. THE EMPTY IMAGE WAS ACQUIRED BUT THE QUALITY WASN'T IDEAL. THEY TOOK NUMEROUS DIFFERENT LATERAL IMAGES WITHOUT SUCCESS, THE SURGEON OPTED TO DISCONTINUE NAVIGATION. NO IMPACT ON PT OUTCOME REPORTED.

    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 UNK