BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23271439 · Received October 10, 2025

    Report

    Report Number
    1723170-2025-03437
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 10, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6): HEMIPARESIS (B)(6): LOWER THAN AVERAGE LIMB COORDINATION AND EQUILIBRIUM G2: THIS EVENT OCCURRED IN BELGIUM, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CITATION: DOI: 10.25259/SNI_198_2025 SUMMARY: BACKGROUND: EPIDERMOID CYSTS ARE SLOW-GROWING, RARE CONGENITAL LESIONS. THEY ARE MOST SEEN IN THE CEREBELLOPONTINE ANGLE, FOURTH VENTRICLE, OR PARASELLAR REGIONS. PATIENTS TYPICALLY BECOME SYMPTOMATIC BETWEEN 20-AND 40 YEARS OF AGE. WE PRESENT A RARE CASE OF A SYMPTOMATIC INTRINSIC BRAINSTEM EPIDERMOID CYST IN A 12-YEAR OLD GIRL WITH ATYPICAL RADIOLOGICAL FEATURES. CASE DESCRIPTION: A 12-YEAR-OLD GIRL PRESENTED WITH PROGRESSIVE GAIT DISTURBANCES, DISEQUILIBRIUM, DIPLOPIA DUE TO RIGHT-SIDED ABDUCENS PARESIS, LEFT-SIDED FACIAL PARESIS (HB GRADE II), HEADACHES, NAUSEA, AND VOMITING OVER THE PAST 6 MONTHS. MAGNETIC RESONANCE IMAGING (MRI) REVEALED AN INTRINSIC LESION OF THE BRAINSTEM NOT PRESENT ON MRI 4 YEARS PRIOR. A MICROSURGICAL GROSS TOTAL RESECTION, INCLUDING RESECTION OF CYST WALL, WAS PERFORMED. THE PATHOLOGY REPORT DIAGNOSED THE LESION AS AN EPIDERMOID CYST. THE PATIENT IMPROVED SIGNIFICANTLY AFTER RESECTION. CONCLUSION: THIS PATHOLOGY REPRESENTS 1% OF ALL INTRACRANIAL TUMORS, AND WITH ONLY 21 DOCUMENTED PEDIATRIC INTRINSIC BRAINSTEM CASES IN MEDICAL LITERATURE, VERY RARELY HAS AN INTRINSIC BRAINSTEM LOCATION.WE DETAIL THE MEDICAL HISTORY, WORK-UP, SURGICAL MANAGEMENT, AND POSTOPERATIVE OUTCOMES, CONTRIBUTING TO THE LIMITED BODY OF KNOWLEDGE REGARDING THIS EXCEPTIONAL ENTITY. REPORTED EVENT(S): THIS ARTICLE WAS A CASE REPORT FOR A 12-YEAR-OLD GIRL. SIX MONTHS POST-OPERATIVE, THE PATIENT EXHIBITED A LOWER-THAN-AVERAGE SCORE ON UPPER LIMB COORDINATION AND EQUILIBRIUM TESTS. THERE WAS ALSO PARTIAL, MAINLY PROXIMAL, PERSISTENT MINOR RIGHT-SIDED HEMIPARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488696 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention