BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 16791577 · Received April 21, 2023

    Report

    Report Number
    1723170-2023-00629
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    February 20, 2023
    Report Date
    April 21, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) SELECT PATIENT INFORMATION CANNOT BE DOCUMENTED IN THE FILE DUE TO REGIONAL PRIVACY REGULATIONS. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G2) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS UNAVAILABLE. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: WANG, Y., GUO, S., WANG, N., LIU, J., CHEN, F., ZHAI, Y., WANG, Y., JIAO, Y., ZHAO, W., FAN, C., XUE, Y., GAO, G. D., JI, P., <(>&<)> WANG, L. (2023). THE CLINICAL AND NEUROCOGNITIVE FUNCTIONAL CHANGES WITH AWAKE BRAIN MAPPING FOR GLIOMAS INVADING ELOQUENT AREAS: INSTITUTIONAL EXPERIENCE AND THE UTILITY OF THE MONTREAL COGNITIVE ASSESSMENT. FRONTIERS IN ONCOLOGY, 13. HTTPS://DOI.ORG/10.3389/FONC.2023.1086118 SUMMARY: OBJECTIVE: AWAKE CRANIOTOMY WITH INTRAOPERATIVE BRAIN FUNCTIONAL MAPPING EFFECTIVELY REDUCES THE POTENTIAL RISK OF NEUROLOGICAL DEFICITS IN PATIENTS WITH GLIOMA INVADING THE ELOQUENT AREAS. HOWEVER, GLIOMA PATIENTS FREQUENTLY PRESENT WITH IMPAIRED NEUROCOGNITIVE FUNCTION. THE PRESENT STUDY AIMED TO INVESTIGATE THE NEUROCOGNITIVE AND FUNCTIONAL OUTCOMES OFGLIOMA PATIENTS AFTER AWAKE BRAIN MAPPING AND ASSESS THE EXPERIENCE OF A TERTIARY NEUROSURGICAL CENTER IN CHINA OVER EIGHT YEARS. METHODS: THIS RETROSPECTIVE STUDY INCLUDED 80 PATIENTS WHO UNDERWENT AWAKE BRAIN MAPPING FOR GLIOMAS INVADING THE ELOQUENT CORTEX BETWEEN JANUARY 2013 AND DECEMBER 2021. CLINICAL AND SURGICAL FACTORS, SUCH AS THE EXTENT OF RESECTION (EOR), PERIOPERATIVE KARNOFSKY PERFORMANCE SCORE (KPS), PROGRESSION-FREE SURVIVAL (PFS), AND OVERALL SURVIVAL (OS), WERE EVALUATED. WE ALSO USED THE MONTREAL COGNITIVE ASSESSMENT (MOCA) TO ASSESS THE NEUROCOGNITIVE STATUS CHANGES. RESULTS: THE MOST FREQUENTLY OBSERVED LOCATION OF GLIOMA WAS THE FRONTAL LOBE (33/80, 41.25%), WHEREAS THE TUMOR PRIMARILY INVADED THE LANGUAGE-RELATED CORTEX (36/80, 45%). MOST PATIENTS HAD SUPRATOTAL RESECTION (11/80, 13.75%) AND TOTAL RESECTION (45/80, 56.25%). THE MEDIAN PFS WAS 43.2 MONTHS, AND THE MEDIAN OS WAS 48.9 MONTHS IN OUR COHORT. THE TRANSIENT (LESS THAN SEVEN DAYS) NEUROLOGICAL DEFICIT RATE WAS 17.5%, WHEREAS THE RATE OF PERSISTENT DEFICIT (LASTING FOR THREE MONTHS) WAS 15%. AT THREE MONTHS OF FOLLOW-UP, MOST PATIENTS (72/80, 90%) HAD KPS SCORES > 80. MEANWHILE, COMPARED TO THE PREOPERATIVE BASELINE TESTS, THE CHANGES IN MOCA SCORES PRESENTED SIGNIFICANT IMPROVEMENTS AT DISCHARGE AND THREE MONTHS FOLLOW-UP TESTS. CONCLUSIONS: AWAKE BRAIN MAPPING IS A FEASIBLE AND SAFE METHOD FOR TREATING GLIOMA INVADING THE ELOQUENT CORTEX, WITH THE BENEFIT OF MINIMIZING NEUROLOGICAL DEFICITS, INCREASING EOR, AND EXTENDING SURVIVAL TIME. THE RESULTS OF MOCA TEST INDICATED THAT BRAIN MAPPING PLAYS A CRITICAL ROLE IN PRESERVING NEUROCOGNITIVE FUNCTION DURING TUMOR RESECTION. REPORTED EVENT: ¿ EIGHTY GLIOMA PATIENTS UNDERWENT AWAKE SURGERY. ELEVEN PATIENTS (13.75%) DEVELOPED NEW TRANSIENT SPEECH AND LANGUAGE-RELATED DEFICITS. ¿ EIGHTY GLIOMA PATIENTS UNDERWENT AWAKE SURGERY. THREE PATIENTS (3.75%) PRESENTED WITH TRANSIENT MOTOR-RELATED SYMPTOMS. ¿ EIGHTY GLIOMA PATIENTS UNDERWENT AWAKE SURGERY. TWELVE PATIENTS DEVELOPED PERSISTENT DEFICITS LASTING FOR THREE MONTHS, INCLUDING FIVE (6.25%) WITH MOTOR-RELATED DISTURBANCE AND SEVEN (8.75%) WITH SPEECH AND LANGUAGE DISTURBANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964913 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown