BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 20097807 · Received August 29, 2024

    Report

    Report Number
    1723170-2024-02433
    Event Type
    Death
    Date Received
    August 29, 2024
    Date of Event
    November 17, 2023
    Report Date
    August 29, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDICAL SAFETY REVIEW WAS PERFORMED. IT WAS DETERMINED THAT THE REPORTED DEATH WAS NOT RELATED TO THE DEVICE, BUT A KNOWN, INHERENT POST-OPERATIVE AND SURGICAL RISK. THE INFORMATION AVAILABLE INDICATES THE DEVICE PERFORMED AS INTENDED IN THIS CASE. H3, H6: NO PRODUCTS HAVE BEEN 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: OPERATIVE NEUROSURGERY 26:502¿510, 2024 HTTPS://DOI.ORG/10.1227/ONS.0000000000000999. SUMMARY: BACKGROUND AND OBJECTIVES: CRANIAL ROBOTICS ARE A BURGEONING FIELD OF NEUROSURGERY. TO DATE, ALL CRANIAL ROBOTIC SYSTEMS DESCRIBED HAVE BEEN COMPUTERIZED, ARM-BASED INSTRUMENTS THAT TAKE UP SIGNIFICANT SPACE IN THE OPERATING ROOM. THE MEDTRONIC STEALTH AUTOGUIDE ROBOT HAS A SMALLER OPERATING ROOM FOOTPRINT AND OFFERS MULTIAXIAL, FRAME-BASED SURGICAL TARGETING. THE AUTHORS SET OUT TO DEFINE THE SURGICAL CHARACTERISTICS OF A NOVEL ROBOTIC PLATFORM FOR BRAIN BIOPSY IN A LARGE PATIENT COHORT. METHODS: PATIENTS WHO UNDERWENT STEREOTACTIC BIOPSY USING THE STEALTH AUTOGUIDE CRANIAL ROBOTIC PLATFORM FROM JULY 2020 TO MARCH 2023 WERE INCLUDED IN THIS STUDY. CLINICAL, SURGICAL, AND HISTOLOGICAL DATA WERE COLLECTED AND ANALYZED. RESULTS: NINETY-SIX CONSECUTIVE PATIENTS (50 FEMALE, 46 MALE) WERE INCLUDED. THE MEAN AGE AT BIOPSY WAS 53.7 ± 18.0 YEARS. THE MEAN TARGET DEPTH WAS 68.2 ± 15.3 MM. THE BIOPSY DIAGNOSTIC TISSUE ACQUISITION RATE WAS 100%. THE MEAN TIME FROM INCISION TO BIOPSY TISSUE ACQUISITION WAS 15.4 ± 9.9 MINUTES. TARGET LESIONS WERE LOCATED THROUGHOUT THE BRAIN: IN THE FRONTAL LOBE (N = 32, 33.3%), PARIETAL LOBE (N = 21, 21.9%), TEMPORAL LOBE (N = 22, 22.9%), DEEP BRAIN NUCLEI/THALAMUS (N = 13, 13.5%), CEREBELLUM (N = 7, 7.3%), AND BRAINSTEM (N = 1, 1.0%). MOST CASES WERE GLIOMAS (N = 75, 78.2%). PATIENTS WERE DISCHARGED HOME ON POSTOPERATIVE DAY 0 OR 1 IN 62.5% OF CASES. A TOTAL OF 7 PATIENTS DEVELOPED POSTOPERATIVE COMPLICATIONS (7.2%). CONCLUSION: THIS CRANIAL ROBOTIC PLATFORM CAN BE USED FOR EFFICIENT, SAFE, AND ACCURATE CRANIAL BIOPSIES THAT ALLOW FOR RELIABLE DIAGNOSIS OF INTRACRANIAL PATHOLOGY IN A MINIMALLY INVASIVE SETTING. REPORTED EVENTS: THIS ARTICLE REVIEWED THE CONSECUTIVE PROCEDURES FOR 96 PATIENTS (46 MALE, 50 FEMALE). THE MEAN AGE AT BIOPSY WAS 53.7 YEARS. THERE WAS 1 POSTOPERATIVE DEATH OF CARDIAC ORIGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765592 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death