BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3190088 · Received June 26, 2013

    Report

    Report Number
    1723170-2013-00475
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WEIGHT INFORMATION RECEIVED AND PROVIDED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, NEW EVENT INFORMATION WAS RECEIVED WHICH CLARIFIED THE REPORTED EVENT AS UNLIKELY TO CAUSE SERIOUS HARM. ALTHOUGH A REPORTABLE MALFUNCTION WAS INITIALLY ALLEGED, IT WOULD BE UNLIKELY TO RESULT IN PATIENT HARM BECAUSE THIS TYPE OF ISSUE OCCURRED DURING A PRE-NAVIGATED STEP, AND WOULD PRECLUDE THERAPEUTIC USE. THE SYSTEM WAS CHECKED AFTER THE CASE AND FOUND FULLY FUNCTIONAL AND THERE HAVE BEEN SUBSEQUENT CASES SINCE WITHOUT ISSUE. THE SYSTEM ARCHIVE RECEIVED WAS CORRUPT AND COULD NOT BE REVIEWED. THE SOFTWARE INVESTIGATION FOUND THAT THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT PROVIDED FROM THE SITE.SOFTWARE INVESTIGATION IS CURRENTLY IN PROGRESS, RESULTS NOT AVAILABLE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PER A PHONE CALL ON (B)(6) 2013 WITH THE MEDTRONIC REPRESENTATIVE WHO ATTENDED THE SURGERY, THE SURGEON WANTED TO TRIAL THE USE OF AN O-ARM FOR A CRANIAL CASE WHERE NAVIGATION WAS NOT ABSOLUTELY NECESSARY. THE REP ASSISTED WITH O-ARM SETUP, INITIAL SPIN AND THE SURGEON MARKED INCISION POINT PRIOR TO DRAPING THE PATIENT. THE REP THEN HAD TO STEP OUT OF THE OR TO ADDRESS A SEPARATE ISSUE AT THE SITE. WHEN HE RETURNED THE SURGEON ALLEGED THAT THERE WAS AN INACCURACY AFTER DRAPING THE PATIENT AND GOING STERILE. THE STAFF WAS USING AN UNFAMILIAR REFERENCE FRAME. PRIOR TO THERAPY, THE SURGEON HAD DECIDED TO DISCONTINUED NAVIGATION (AS IT WAS NOT NECESSARY FOR THIS CASE) AND CONTINUED THE SURGERY WITH NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE IN A COMBINATION ENT/NEURO CRANIOTOMY, THE SURGEON ALLEGED A 3CM INACCURACY. THE SURGEON OPTED TO DISCONTINUE NAVIGATION TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290501 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR