BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 21374079 · Received February 13, 2025

    Report

    Report Number
    1723170-2025-00653
    Event Type
    Death
    Date Received
    February 13, 2025
    Date of Event
    December 24, 2024
    Report Date
    February 13, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3) EVENT DATE IS THE ACCEPTED 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. 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

    SOBSTYL, M., KARAMON, K., STAPINSKA-SYNIEC, A., COMPARATIVE ANALYSIS OF HEMORRHAGIC COMPLICATIONS IN DEEP BRAIN STIMULATION: MICROELECTRODE RECORDING VERSUS MACROSTIMULATIONE-DOES THE TECHNIQUE MATTER? WORLD NEUROSURGERY, 2025. 194(123634) HTTPS://DOI.ORG/10.1016/ J.WNEU.2024.123634 - BACKGROUND: HEMORRHAGE IS A DANGEROUS COMPLICATION OF DEEP BRAIN STIMULATION (DBS) SURGERY, BUT A COMPREHENSIVE EXPLANATION OF THE ASSOCIATED RISK FACTORS REMAINS INCONCLUSIVE, PARTICULARLY APPLICATION OF MICRO ELECTRODE RECORDING (MER) COMPARED WITH MACRO STIMULATION (NON-MER)-BASED DBS PROCEDURES. WE CONDUCTED A COMPARATIVE ANALYSIS OF MER AND MACRO STIMULATION TECHNIQUES, EVALUATING THE IMPACT OF BRAIN PENETRATIONS BY MICROELECTRODE GUIDING CANNULAS ON THE OCCURRENCE OF INTRACRANIAL HEMORRHAGIC EVENTS. - METHODS: THIS RETROSPECTIVE STUDY INCLUDED ALL DBS PROCEDURES (MER-BASED AND NON-MEREBASED) PERFORMED AT A SINGLE MEDICAL CENTER FROM NOVEMBER 2008 TO JUNE 2023. PATIENTS UNDERWENT COMPREHENSIVE PREOPERATIVE AND POSTOPERATIVE EVALUATIONS, INCLUDING POSTOPERATIVE COMPUTED TOMOGRAPHY TO ASSESS LEAD PLACEMENT AND INTRACRANIAL BLEEDING, CATEGORIZED AS SYMPTOMATIC OR ASYMPTOMATIC. STATISTICAL ANALYSES WERE CONDUCTED TO ASCERTAIN THE CORRELATION BETWEEN DIFFERENT SURGICAL TECHNIQUES AND THE RISK OF HEMORRHAGIC COMPLICATIONS. - RESULTS: IN A COHORT OF 618 PATIENTS, 1096 ELECTRODES WERE IMPLANTED DURING 672 CONSECUTIVE DBS PROCEDURES. THERE WERE 21 ASYMPTOMATIC AND 6 SYMPTOMATIC INTRACRANIAL HEMORRHAGES (ICHS), INCLUDING 1 DEATH. THE BLEEDING RATE WAS 4.37% PER PATIENT AND 2.92% PER ELECTRODE. PATIENTS WHO DEVELOPED HEMATOMAS WERE MORE PREVALENT IN THE MER GROUP (25 CASES) COMPARED WITH THE NON-MER GROUP (2 CASES). THE MER GROUP HAD A HIGHER MEAN NUMBER OF BRAIN PENETRATIONS BY GUIDING CANNULAS. - CONCLUSIONS: DBS PROCEDURES ARE GENERALLY SAFE, WITH ONLY 0.97% RESULTING IN LONG-TERM OR PERMANENT DEFICITS. ALL SYMPTOMATIC ICH OCCURRED IN MER-BASED PROCEDURES, WHEREAS MACROSTIMULATION WAS ASSOCIATED WITH ONLY 2 ASYMPTOMATIC ICH CASES. THE HIGHER NUMBER OF BRAIN PENETRATIONS IN MER CORRELATES WITH HIGHER BLEEDING RATES. REPORTABLE EVENTS: 1 PATIENT DIED; INTRAVENTRICULAR BLEEDING INTO THE THIRD, FOURTH, AND LATERAL VENTRICLES, INTRAPARENCHYMAL BLEEDING IN THE LEFT FRONTAL LOBE, BLEEDING TO CEREBELLOMEDULLARY CISTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119796 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death