BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17560296 · Received August 16, 2023

    Report

    Report Number
    1723170-2023-01491
    Event Type
    Death
    Date Received
    August 16, 2023
    Date of Event
    May 27, 2023
    Report Date
    August 25, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN GERMANY. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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.

    Additional Manufacturer Narrative · 0

    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: WORLD NEUROSURG. (2023). HTTPS://DOI.ORG/10.1016/J.WNEU.2023.05.108. SUMMARY: OBJECTIVE: THE INDICATION FOR PERFORMING BIOPSIES IN PATIENTS WITH DIFFUSE LESIONS IN THE BRAIN STEM IS CONTROVERSIAL. THE POSSIBLE RISKS ASSOCIATED WITH THE TECHNICALLY CHALLENGING INTERVENTIONS MUST BE BALANCED AGAINST CLARIFYING THE DIAGNOSIS AND THE POSSIBLE THERAPEUTIC OPTIONS. WE REVIEWED THE FEASIBILITY, RISK PROFILE, AND DIAGNOSTIC YIELD OF DIFFERENT BIOPSY TECHNIQUES IN A PEDIATRIC COHORT. METHODS: WE RETROSPECTIVELY INCLUDED ALL PATIENTS AGED < 18 YEARS WHO HAD UNDERGONE BIOPSY OF THE CAUDAL BRAINSTEM REGION (PONS, MEDULLA OBLONGATA) AT OUR PEDIATRIC NEUROSURGICAL CENTER FROM 2009 TO 2022. RESULTS: WE IDENTIFIED 27 CHILDREN. BIOPSIES WERE PERFORMED USING FRAMELESS STEREOTACTIC (VARIOGUIDE; N [12), ROBOTIC-ASSISTED (AUTOGUIDE; N [ 4), ENDOSCOPIC (N [3), AND OPEN BIOPSY (N [ 8) TECHNIQUES. INTERVENTION RELATED MORTALITY WAS NOT OBSERVED. THREE PATIENTS EXPERIENCED A TRANSIENT POSTOPERATIVE NEUROLOGICAL DEFICIT. NO PATIENT EXPERIENCED INTERVENTION-RELATED PERMANENT MORBIDITY. BIOPSY YIELDED THE HISTOPATHOLOGICAL DIAGNOSIS IN ALL 27 CASES. MOLECULAR ANALYSIS WAS FEASIBLE FOR 97% OF THE CASES. THE MOST COMMON DIAGNOSIS WAS H3K27M MUTATED DIFFUSE MIDLINE GLIOMA (60%). LOW-GRADE GLIOMAS WERE IDENTIFIED IN 14% OF PATIENTS. OVERALL SURVIVAL WAS 62.5% AFTER 24 MONTHS OF FOLLOW-UP. CONCLUSIONS: BIOPSIES OF THE CAUDAL BRAINSTEM IN CHILDREN WERE FEASIBLE AND SAFE IN THE PRESENTED SETUP. THE AMOUNT OF TUMOR MATERIAL ACQUIRED ALLOWING FOR AN INTEGRATED DIAGNOSIS AND WAS OBTAINED AT REASONABLE RISK. THE SELECTION OF THE SURGICAL TECHNIQUE DEPENDS ON THE TUMOR LOCATION AND GROWTH PATTERN. WE RECOMMEND THE PERFORMANCE OF BRAINSTEM TUMOR BIOPSIES IN CHILDREN AT SPECIALIZED CENTERS TO BETTER UNDERSTAND THE BIOLOGY AND ENABLE POSSIBLE NOVEL THERAPEUTIC OPTIONS. REPORTED EVENT(S): THERE WERE 27 PATIENTS IN THIS STUDY. 11 WERE GIRLS, AND THEIR MEDIAN AGE AT SURGERY WAS 5 YEARS. FOLLOW-UP INFORMATION WAS AVAILABLE FOR 24 PATIENTS. 3 PATIENTS RECEIVED TARGETED THERAPY BASED ON THE MOLECULAR PROFILING: 1 PATIENT WITH AN ANAPLASTIC ASTROCYTOMA RECEIVED ABEMACICLIB AND HAD A POSTOPERATIVE SURVIVAL OF 48 MONTHS. THE SECOND PATIENT HAD A DIFFUSE GLIOMA (H3K27 WILD-TYPE), WAS TREATED WITH DASATINIB, AND SURVIVED 17 MONTHS AFTER SURGERY. THE THIRD PATIENT WAS TREATED WITH PONATINIB BASED ON THE MOLECULAR PROFILING OF A DIFFUSE MIDLINE GLIOMA (H3K27 MUTATED), WITH A POSTOPERATIVE SURVIVAL OF 10 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785570 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS
    987589 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Death