BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5748642 · Received June 24, 2016

    Report

    Report Number
    1723170-2016-01231
    Event Type
    Death
    Date Received
    June 24, 2016
    Date of Event
    May 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED. DATE OF PATIENT DEATH WAS NOT PROVIDED, THEREFORE DATE OF AWARENESS AND PUBLICATION WAS USED. CITATION: RUECKRIEGEL SM, LINSENMANN T, KESSLER AF, HOMOLA GA, BARTSCH AJ, ERNESTUS R-I, WESTERMAIER T, LOHR M. FEASIBILITY OF THE COMBINED APPLICATION OF NAVIGATED PROBABILISTIC FIBER TRACKING AND NAVIGATED ULTRASONOGRAPHY IN BRAIN TUMOR SURGERY. WORLD NEUROSURG. 2016; 90:306-314. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.02.119. NO ALLEGATION OR INFORMATION TO SUGGEST THAT PATIENT DEATH WAS RELATED TO USE OF THE MEDTRONIC SYSTEM OR INABILITY TO NAVIGATE THE ULTRASOUND. PER ARTICLE, THE CAUSE OF FAILED REFERENCING OF NAVIGATED ULTRASONOGRAPHY WAS NOT ABLE TO BE DETERMINED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTH STATION.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE, FOLLOWING UP WITH THE JOURNAL AUTHOR, REPORTED THAT, "IN THE DESCRIBED CASE, IT WAS NOT POSSIBLE TO REFERENCE THE ULTRASOUND DEVICE TO THE STEALTH STATION. WE TRIED VARIOUS TIMES TO REFERENCE THE ULTRASOUND USING THE REFERENCE DEVICE (THE SAME WAY WE DID IN ALL THE OTHER CASES), BUT THE STEALTH STATION DID NOT RECOGNIZE THE DEVICE, SO WE PROCEEDED WITHOUT NAVIGATED ULTRASOUND. A REASON FOR THE REFERENCE FAILURE WAS NOT EVIDENT. HOWEVER, NAVIGATION WITH THE POINTER WAS ACCURATE. " THERE IS NO ALLEGATION TO SUGGEST THAT REPORTED DIFFICULTIES REPORTED ABOVE CAUSED OR CONTRIBUTED TO THE PATIENT POSTOPERATIVE CARDIOPULMONARY COMPLICATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTH STATION. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE, COMBINATION WITH NAVIGATED ULTRASONOGRAPHY TO CONTROL BRAIN SHIFT WAS ACCOMPLISHED IN 10 PATIENTS, BUT REFERENCING THE NAVIGATED ULTRASONOGRAPHY FAILED IN 1 PATIENT (PATIENT 6); IT WAS NOT POSSIBLE TO CLARIFY THE REASON FOR THE REFERENCE FAILURE. POSTOPERATIVELY, 10 PATIENTS SHOWED STABLE OR IMPROVED NEUROLOGIC FUNCTIONS, AND 1 PATIENT (PATIENT NUMBER 6) DIED AS A RESULT OF POSTOPERATIVE CARDIOPULMONARY COMPLICATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTH STATION. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402164 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death