BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24803811 · Received April 7, 2026

    Report

    Report Number
    1723170-2026-00554
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    June 21, 2024
    Report Date
    April 7, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN ITALY, 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: 10.3171/2024.4.JNS232968. SUMMARY: OBJECTIVE THE ONCO-FUNCTIONAL BALANCE REPRESENTS THE PRIMARY GOAL IN NEURO-ONCOLOGY. THE INCREASING USE OF NAVIGATED TRANSCRANIAL MAGNETIC STIMULATION (NTMS) ALLOWS THE NONINVASIVE CHARACTERIZATION OF CORTICAL FUNCTIONAL ANATOMY, AND ITS RELIABILITY FOR MOTOR AND LANGUAGE MAPPING HAS PREVIOUSLY BEEN VALIDATED. CALCULATION AND ARITHMETIC PROCESSING HAS NOT BEEN STUDIED WITH NTMS SO FAR. IN THIS STUDY, THE AUTHORS PRESENT THEIR PRELIMINARY DATA CONCERNING NTMS CALCULATION. METHODS THE AUTHORS DESIGNED A MONOCENTRIC PROSPECTIVE STUDY, ADOPTING AN INTERNAL PROTOCOL TO USE NTMS FOR PREOPERATIVE PLANNING, INCLUDING ARITHMETIC PROCESSING. WHEN AWAKE SURGERY WAS POSSIBLE, ACCORDING TO THE PATIENTS¿ CONDITIONS, NTMS POINTS WERE USED TO GUIDE DIRECT CORTICAL STIMULATION (DCS), I.E., THE GOLD STANDARD FOR CORTICAL MAPPING. NAVIGATED TMS¿BASED TRACTOGRAPHY WAS USED FOR SURGICAL PLANNING. STATISTICAL ANALYSES ON THE NTMS AND DCS POINTS WERE PERFORMED. RESULTS FROM FEBRUARY 2021 TO OCTOBER 2023, 61 PROCEDURES FOR NTMS CALCULATION MAPPING WERE PERFORMED. THE CLINICAL EVALUATION, INCLUDING PRE- AND POSTOPERATIVE EVALUATIONS (3 MONTHS AFTER SURGERY), DEMONSTRATED A GOOD CLINICAL OUTCOME WITH PRESERVATION OF ARITHMETIC FUNCTION AND RECOVERY (92.8% OF PATIENTS). BETWEEN THE AWAKE AND ASLEEP SURGERY GROUPS, THE POSTOPERATIVE CLINICAL RESULTS WERE COMPARABLE AT THE 3-MONTH FOLLOW-UP, WITH > 90% OF THE PATIENTS ACHIEVING IMPROVED CALCULATION FUNCTION. THE SURGICAL STRATEGY ADOPTED WAS AIMED AT SPARING NTMS POSITIVE POINTS IN ASLEEP PROCEDURES, WHEREAS NTMS AND DCS POSITIVE POINTS WERE NOT REMOVED IN AWAKE PROCEDURES. OVERALL, 62% OF THE POSITIVE POINTS FOR CALCULATION FUNCTIONS WERE EXPOSED BY CRANIOTOMY AND 85% WERE SPARED DURING SURGERY. NONE OF THE PATIENTS DEVELOPED NTMS-RELATED SEIZURES. DIFFUSION TENSOR IMAGING FIBER TRACKING BASED ON NTMS POSITIVE POINTS FOR CALCULATION WAS USED. THE WHITE MATTER FIBER TRACTS INVOLVED IN CALCULATION FUNCTIONS WERE THE ARCUATE FASCICULUS (56%) AND FRONTAL ASLANT TRACT (22%). WHEN NTMS AND DCS POINTS WERE COMPARED IN AWAKE SURGERY (N = 10 PATIENTS), A SENSITIVITY OF 31.71%, SPECIFICITY OF 85.76%, POSITIVE PREDICTIVE VALUE OF 22.41%, NEGATIVE PREDICTIVE VALUE OF 90.64%, AND ACCURACY OF APPROXIMATELY 69% WERE ACHIEVED. CONCLUSIONS BASED ON THE AUTHORS¿ PRELIMINARY DATA, NTMS CAN BE AN ADVANTAGEOUS TOOL TO STUDY COGNITIVE FUNCTIONS, AIMED AT MINIMIZING NEUROLOGICAL IMPAIRMENT. THE POSTOPERATIVE CLINICAL OUTCOME FOR PATIENTS WHO UNDERWENT OPERATION WITH NTMS WAS VERY GOOD. CONSIDERING THESE RESULTS, NTMS HAS PROVED TO BE A FEASIBLE METHOD TO MAP COGNITIVE AREAS INCLUDING THOSE FOR CALCULATION FUNCTIONS. FURTHER ANALYSES ARE ARE NEEDED TO VALIDATE THESEDATA. FINALLY, OTHER COGNITIVE FUNCTIONS (E.G., VISUOSPATIAL) MAY BE EXPLORED WITH NTMS. REPORTED EVENT(S): THERE WERE 83 PATIENTS WITH A MEAN AGE OF 51.4 YEARS INCLUDED IN THIS STUDY. THE SEX DISTRIBUTION WAS COMPARABLE (1:1 MALE/FEMALE). 12% DEVELOPED A TRANSIENT IMPAIRMENT IMMEDIATELY AFTER SURGERY. 98% OF THESE HAD RECOVERED FUNCTION BY THE 3-MONTH FOLLOW-UP (2% HAD A MODERATE DEFICIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860674 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention