BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2150567 · Received June 22, 2011

    Report

    Report Number
    1723170-2011-01126
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE AT TIME OF THIS REPORT. MEDTRONIC INVESTIGATION FOUND THAT THE RN RUNNING THE SYSTEM MOVED THE TRAJECTORY UNINTENTIONALLY AND THUS SHE REPORTED THAT IT WAS "OFF". THERE WAS NO ALLEGATION OF INACCURACY.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL NAVIGUS BIOPSY, THEY WERE HAVING DIFFICULTY GETTING THE BIOPSY NEEDLE TO TRACK. THE MEDTRONIC REPRESENTATIVE DETERMINED THAT THEY HAD NOT YET LOCKED THEIR TRAJECTORY AND WALKED THEM THROUGH RE-SETTING THE ENTRY POINT AND ALIGNING THE GUIDANCE VIEW. THE SITE REP REPORTED THAT THE TARGET ALIGNMENT ERROR WAS HIGH, AND EVEN WHEN MOVING THE GUIDE STEM TO THE FARTHEST LIMIT THEY WERE NOT ABLE TO GET IT ALIGNED. THE SURGEON THEN MOVED THE ANGLED BASE OVER SLIGHTLY TO GET THE CORRECT ANGLE AND THEY WERE ABLE TO GET THE ERROR BELOW 2.0. AT THIS POINT THEY ALLEGED THAT THE TRAJECTORY APPEARED TO BE "OFF". WHEN ASKED IF NAVIGATION HAD BEEN ACCURATE UP UNTIL THAT POINT THE SITE REP WAS UNCLEAR IF IT HAD. THEY DECLINED ANY FURTHER TROUBLESHOOTING. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    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