BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2944277 · Received February 5, 2013

    Report

    Report Number
    1723170-2013-00072
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE AT TIME OF THIS REPORT, HOWEVER, HAS BEEN REQUESTED. PATIENT LOGS/FILES HAVE BEEN REQUESTED, HOWEVER, HAVE NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION OF SOFTWARE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT, WHILE IN A CRANIAL TUMOR RESECTION, THE SYSTEM WAS UNRESPONSIVE DURING TRACER REGISTRATION CALCULATION FOR 10 MINUTES AND WOULD NOT ADVANCE. THE SITE RE-LAUNCHED THE CRANIAL APPLICATION, RE-TRACED THE PATIENT, AND PROCEEDED. THE SURGERY WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48227 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1