BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 7758091 · Received August 7, 2018

    Report

    Report Number
    1723170-2018-03863
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    November 17, 2017
    Report Date
    August 7, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE REPORTS THAT THE MEAN PATIENT AGE WAS 37 AND THE CONSISTED OF MALE PATIENTS IN THE STUDY. THEREFORE 37 YEARS OLD AND MALE WERE USED. EVENT DATE IS APPROXIMATED. DATE PROVIDED IS WHEN THE JOURNAL ARTICLE WAS PUBLISHED. CITATION: STENO A. HOLLY V. MENDEL P. ET AL. NAVIGATED 3D¿ULTRASOUND VERSUS CONVENTIONAL NEURONAVIGATION DURING AWAKE RESECTIONS OF ELOQUENT LOW-GRADE GLIOMAS: A COMPARATIVE STUDY AT A SINGLE INSTITUTION. (2018). ACTA NEUROCHIR (2018) 160:331¿342. HTTPS://DOI.ORG/10.1007/S00701-017-3377-8. THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED. DEVICE UDI NOT PROVIDED AS ACTUAL PRODUCT USED FOR THIS STUDY IS UNKNOWN. DEVICE MANUFACTURING DATE IS DEPENDENT ON SERIAL NUMBER, THEREFORE, UNAVAILABLE. NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE OR FROM THE AUTHORS. THE AUTHOR COULD NOT PROVIDE ANY ADDITIONAL INFORMATION OR INSIGHT AS HE WAS NOT AT THE SITE WHEN THE SURGERIES WERE PERFORMED. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER FOR EVALUATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S SURGICAL NAVIGATION SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE WAS FORWARDED BY MEDTRONIC REPRESENTATIVE. ARTICLE INDICATED THE USE OF SURGICAL NAVIGATION SYSTEM. THIS IS MEDICAL DEVICE REPORT (MDR) TWO OF TWO. SEE 1723170-2018-03863 FOR THE OTHER CASE. BACKGROUND THE DATA SHOWING USEFULNESS OF NAVIGATED 3D¿ ULTRASOUND (3DUS) DURING AWAKE RESECTIONS OF ELOQUENT GLIOMAS ARE SPARSE. RESULTS OF SURGERIES PERFORMED USING 3DUS WERE NEVER COMPARED TO PROCEDURES GUIDED BY STANDARD NEURONAVIGATION. THE AIM OF THIS WORK IS TO ASSESS THE EFFECTIVENESS OF 3DUS DURING AWAKE RESECTIONS OF ELOQUENT LOW-GRADE GLIOMAS (LGGS) BY COMPARING SURGICAL RESULTS OF TWO SERIES OF PATIENTS OPERATED ON USING CONVENTIONAL NEURONAVIGATION AND USING 3DUS. TO OUR KNOWLEDGE, A SIMILAR STUDY IS LACKING IN THE LITERATURE. METHODS DURING A 4-YEAR PERIOD (SEPTEMBER 2006 TO AUGUST 2010) 21 AWAKE RESECTIONS OF LGGS GUIDED BY NEURONAVIGATION (SERIES 1, S1) WERE CONSECUTIVELY PERFORMED IN DEPARTMENT OF NEUROSURGERY IN (B)(6). DURING ANOTHER 4-YEAR PERIOD (AUGUST 2010 TO JULY 2014) 28 AWAKE RESECTIONS OF LGGS GUIDED BY 3DUS (SERIES 2, S2) WERE CONSECUTIVELY CONDUCTED. IN BOTH PATIENTS SERIES, THE ELOQUENT CORTICAL AND SUBCORTICAL STRUCTURES WERE INTRAOPERATIVELY DETECTED BY DIRECT ELECTRICAL STIMULATION. EXTENT OF TUMOR RESECTION (EOR) AND FUNCTIONAL OUTCOME IN BOTH SERIES WERE COMPARED. RESULTS: EOR WAS SIGNIFICANTLY GREATER (P = 0.022) IN S2 (MEDIAN = 93.25%; MEAN = 86.79%), AS COMPARED TO S1 (MEDIAN 87.1%; MEAN = 75.85%). ONE PERMANENT MINOR DEFICIT IN S1 AND 2 MINOR DEFICITS IN S2 OCCURRED, THE DIFFERENCE WAS NOT SIGNIFICANT (P = 0.999). IN TWO PATIENTS IN S1, THE RESECTION TERMINATED PREMATURELY: THE REASONS WERE INTRAOPERATIVE NAVIGATION FAILURE AND INTRAOPERATIVE TODD¿S HEMIPARESIS IN TWO PATIENTS FROM S1 (BOTH REFUSED REOPERATION AND PREFERRED ONCOLOGICAL TREATMENT). CONCLUSIONS: OUR WORK REPRESENTS THE FIRST STUDY COMPARING RESULTS OF SURGERIES GUIDED BY 3DUS VERSUS CONVENTIONAL NAVIGATION. THE EXTENT OF AWAKE RESECTIONS OF ELOQUENT LGG GUIDED BY 3DUS WAS GREATER COMPARING TO AWAKE RESECTIONS GUIDED BY STANDARD NEURONAVIGATION; USE OF 3DUS HAD NO IMPACT ON THE NUMBER OF NEW PERMANENT DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597887 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TREON

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR