BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4221330 · Received November 3, 2014

    Report

    Report Number
    1723170-2014-01174
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED; ANALYSIS CONFIRMED A 2.0 ERROR METRIC WITH POINTMERGE REGISTRATION ON A MAGNETIC RESONANCE IMAGING (MR) SERIES. IT IS SUSPECTED THAT THE RE-POSITIONING OF THE PATIENT'S ARM MAY HAVE ATTRIBUTED TO THE INACCURACY. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SYNERGY CRANIAL TUMOR RESECTION PROCEDURE, THE SURGEON ALLEGED A 17MM INACCURACY IN BOTH SUPERIOR/INFERIOR AND MEDIAL/LATERAL DIRECTIONS. IMMEDIATELY AFTER POINTMERGE REGISTRATION, THE SURGEON DEEMED BEING ACCURATE. THE PATIENT'S ARM WAS THEN RE-POSITIONED, AND BECAUSE THE MAYFIELD AND VERTEK ARM SEEMED TO NOT MOVE, THE SURGEON OPTED NOT TO RE-VERIFY ACCURACY. THE ONLY INSTRUMENT USED WAS THE PASSIVE PLANAR BLUNT. WHEN THE INACCURACY WAS NOTED, THE SURGEON CHOSE TO DISCONTINUE THE USE OF THE NAVIGATION SYSTEM TO CONTINUE AND COMPLETE THE PROCEDURE. THE DELAY IN THE SURGERY WAS 2 HOURS AND IT WAS REPORTED THAT MORE THAN NORMAL TISSUE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701142 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention