BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3579896 · Received January 16, 2014

    Report

    Report Number
    1723170-2014-00038
    Event Type
    Death
    Date Received
    January 16, 2014
    Date of Event
    November 14, 2012
    Report Date
    October 16, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO FILE A CORRECTION MDR REGARDING ADVERSE EVENT INADVERTENTLY LEFT OFF THE PREVIOUS MDR SUBMISSIONS. AS PREVIOUSLY REPORTED THE DATE OF PATIENT DEATH WAS REPORTED TO HAVE OCCURRED FOLLOWING A PROCEDURE ON (B)(6) /2012. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE AND PERFORMED A SYSTEM CHECKOUT. THE SYSTEM PERFORMED PROPERLY FOR ALL TESTING.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNAVAILABLE PER JAPAN PRIVACY LAWS. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM DUE TO THE INACCURACY NOTED. AT THE CLOSE OF THAT PROCEDURE, ON (B)(6) 2012, THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO PARTS WERE RETURNED TO MANUFACTURER FOR ANALYSIS AS THERE IS NO ALLEGATION THAT THE MEDTRONIC NAVIGATION SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, ONLY THAT THE PATIENT'S CONDITION WAS NOT CONDUCIVE TO USE OF THE NAVIGATION SYSTEM FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT ON (B)(6) 2012, A THORACIC-10 TO LUMBAR-2 FUSION FOR A THORACIC-12 COMPRESSED SPINAL FRACTURE WAS SCHEDULED TO BE PERFORMED WITH THE MEDTRONIC NAVIGATION SYSTEM. THE MEDTRONIC REPRESENTATIVE CAUTIONED THE SURGEON, BEFORE THE PROCEDURE BEGAN, THAT DUE TO THE TYPE OF SURGERY AND THE SEVERITY OF THE FRACTURE, THAT OPTIMAL NAVIGATIONAL ACCURACY MAY NOT BE ENSURED. THE SURGEON WANTED TO ATTEMPT REGISTRATION WITH THE NAVIGATION SYSTEM. THE SURGEON COMPLETED THE REGISTRATION FOR THORACIC-12 AND THE NAVIGATION SYSTEM WAS USED FOR THE VERTEBROPLASTY WITHOUT ISSUE. THE SURGEON THEN CHECKED ACCURACY ON T10, T11, L1 AND L2. THE SURGEON DETERMINED THAT ACCURACY WAS NOT SUFFICIENT TO PROCEED WITH USE OF THE NAVIGATION SYSTEM. THE SURGEON OPTED NOT TO USE THE NAVIGATION SYSTEM AND COMPLETED THE PROCEDURE UNDER FLUOROSCOPIC CONTROL INSTEAD. AFTER THE PROCEDURE, THERE WAS NO INQUIRY OR COMMUNICATION FROM THE SITE AND NO FURTHER INFORMATION REGARDING THIS PROCEDURE. ON (B)(6) 2013, IT WAS REPORTED TO A MEDTRONIC REPRESENTATIVE THAT THE PATIENT HAD BECOME WORSE FOLLOWING THE PROCEDURE, AND SUBSEQUENTLY DIED. IT WAS NOTED THAT THE NAVIGATION SYSTEM WAS NOT USED ON THE PATIENT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43661 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 Death