BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2991523 · Received March 6, 2013

    Report

    Report Number
    1723170-2013-00153
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 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

    NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A 1CM INACCURACY WHILE IN A SYNERGY CRANIAL PROCEDURE. THE SURGEON PLACED ELECTRODES AND AFTER REGISTRATION HE DEEMED THEY WERE ACCURATE. THEN WENT STERILE WHILE STILL TRACKING NORMALLY, THE SURGEON REMOVED A VERY LARGE BONE FLAP. PLACING ELECTRODES, AGAIN, THE SURGEON WENT BACK TO THE SKULL AND IT SHOWED BEING ABOVE THE SKIN; AT THIS POINT THE SURGEON ALLEGED THE INACCURACY ANTERIORLY A FEW MILLIMETERS AND MEDIALLY TO THE LEFT, LESS THAN 1 CENTIMETER. IT WAS REPORTED THAT THE REFERENCE FRAME WAS ON THE VERTEK ARM SOLIDLY, NO MOVEMENT; THE PATIENT PINNED TIGHTLY IN THE MAYFIELD. THERE IS NO NOTATION THAT THE FRAME WAS BUMPED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITH THE CONTINUED USE OF THE STEALTHSTATION S7 STILL NOTING THE INACCURACY. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95197 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR