BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 23863111 · Received December 22, 2025

    Report

    Report Number
    1723170-2025-03957
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 2, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CAVALHEIRO, S., PADUA, W.L., NÔVO, P.C., DE SOUZA MELO, T.C., DASTOLI, P.A., SUZUKI, F., SILVA DA COSTA, M.D. ENDOSCOPIC ULTRASONIC ASPIRATOR¿ASSISTED RESECTION FOR PEDIATRIC HYPOTHALAMIC HAMARTOMAS: OUTCOMES AND TECHNICAL NUANCES. CHILDREN'S NERVOUS SYSTEM. 2025. VOLUME 41, ARTICLE NUMBER 340. DOI.ORG/10.1007/S00381-025-07014-W HYPOTHALAMIC HAMARTOMAS (HHS) ARE RARE DEVELOPMENTAL LESIONS FREQUENTLY ASSOCIATED WITH DRUG-RESISTANT EPILEPSY. MULTIPLE SURGICAL TECHNIQUES HAVE BEEN DESCRIBED, BUT THE OPTIMAL STRATEGY REMAINS CONTROVERSIAL. ENDOSCOPIC APPROACHES HAVE EMERGED AS MINIMALLY INVASIVE OPTIONS, YET TECHNICAL LIMITATIONS PERSIST, PARTICULARLY IN LARGER OR FIRM LESIONS. THIS ARTICLE AIMS TO DESCRIBE THE TECHNICAL NUANCES, SAFETY, AND CLINICAL OUTCOMES OF ENDOSCOPIC RESECTION OF PEDIATRIC HHS ASSISTED BY A NEUROENDOSCOPIC ULTRASONIC ASPIRATOR (NUA). METHODS WE RETROSPECTIVELY REVIEWED 21 PEDIATRIC PATIENTS WHO UNDERWENT PURELY ENDOSCOPIC HH RESECTION WITH NUA ASSISTANCE BETWEEN 2009 AND 2025. DEMOGRAPHIC, CLINICAL, AND RADIOLOGICAL DATA WERE COLLECTED. SEIZURE OUTCOMES WERE EVALUATED USING THE ENGEL CLASSIFICATION AT 12 MONTHS, AND RESECTION EXTENT WAS ASSESSED WITH POSTOPERATIVE MRI. RESULTS FOURTEEN PATIENTS (66.6%) WERE MALE, WITH A MEAN AGE AT SURGERY OF 6.1 YEARS (RANGE, 0.4¿17.5). ACCORDING TO THE DELALANDE CLASSIFICATION, LESIONS INCLUDED 4 TYPE I, 9 TYPE II, 5 TYPE III, AND 3 TYPE IV. THE MEAN PREOPERATIVE VOLUME WAS 1.9 CC. GROSS-TOTAL RESECTION WAS ACHIEVED IN 19 PATIENTS (90%). AT 12 MONTHS, 14 OF 18 EVALUABLE PATIENTS (77.7%) ACHIEVED ENGEL CLASS I SEIZURE FREEDOM, WHILE 4 (22.2%) HAD ENGEL CLASS IIB OUTCOMES (>90% REDUCTION). THERE WAS NO OPERATIVE MORTALITY. COMPLICATIONS INCLUDED TRANSIENT HYPONATREMIA IN 28% AND OBESITY IN 10%, ALL MANAGED CONSERVATIVELY. CONCLUSION ENDOSCOPIC RESECTION OF HHS USING AN ULTRASONIC ASPIRATOR IS A SAFE AND EFFECTIVE TECHNIQUE, PROVIDING HIGH RATES OF SEIZURE FREEDOM WITH LOW MORBIDITY. THIS APPROACH EXPANDS THE INDICATIONS OF PURELY ENDOSCOPIC SURGERY FOR HHS, PARTICULARLY IN SETTINGS WHERE LASER ABLATION IS NOT AVAILABLE. REPORTED EVENTS: COMPLICATIONS INCLUDED 28% WERE HYPONATREMIA 2 CASES OF AGGRESSIVE BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1943030 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention