BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3951239 · Received July 22, 2014

    Report

    Report Number
    1723170-2014-00783
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER FIELD NOT SUFFICIENT TO HOLD ALL DIGITS, SHOULD READ: (B)(4). PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. THE DECISION TO FILE THIS REPORT WAS DERIVED FROM FINDINGS OF AN INTERNAL MANUFACTURER CAPA ADDRESSING DELAY OF THERAPY TO THE PATIENT. SOFTWARE INVESTIGATION COMPLETED. INVESTIGATION FOUND CAUSE COULD NOT BE DETEREMINED AS THE BEHAVIOR COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, DURING A CRANIAL TUMOR BIOPSY PROCEDURE THE SURGEON WAS UNABLE TO OBTAIN A SUCCESSFUL PATIENT REGISTRATION. THE PATIENT WAS PRONE AND THERE WERE 4 FIDUCIALS AROUND EACH EAR, ONE ON THE BACK OF THE HEAD AND THE REMAINDER NEAR THE FRONT OF THE HEAD. THE SURGEON TRIED TWO DIFFERENT REGISTRATION TECHNIQUES WITH NO RESOLUTION. THE SURGEON CHOSE TO USE BONE FIDUCIALS AND SCREWED IN 5 SKULL MOUNTED FUDUCIALS AND THE PATIENT WAS SENT FOR A NEW COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT WAS THEN RE-POSITIONED AND THE CT AND MAGNETIC RESONANCE IMAGING (MRI) SCANS WERE SUCCESSFULLY MERGED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME. THE DELAY TO THE PROCEDURE WAS APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427574 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR