BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 19088808 · Received April 11, 2024

    Report

    Report Number
    1723170-2024-01057
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 11, 2024
    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

    CONTINUATION OF D10: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK NAV COMP (UNKNOWN STEALTH AUTOGUIDE). PRODUCT ID: UNK NAV COMP (UNKNOWN STEALTHNAVIGUS). G2: THIS EVENT OCCURRED IN ITALY, SEE E1-E3. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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: HTTPS://DOI.ORG/10.1007/S00381-024-06349-0. SUMMARY: BACKGROUND AND OBJECTIVES: ROBOT-ASSISTED BIOPSIES HAVE GAINED POPULARITY IN THE LAST YEARS. MOST ROBOTIC PROCEDURES ARE PERFORMED WITH A FLOOR-BASED ROBOTIC ARM. RECENTLY, MEDTRONIC STEALTH AUTOGUIDE, A MINIATURIZED ROBOTIC ARM THAT WORK TOGETHER WITH AN OPTICAL NEURONAVIGATION SYSTEM, WAS LAUNCHED. ITS APPLICATION IN PEDIATRIC CASES IS RELATIVELY UNEXPLORED. IN THIS STUDY, WE RETROSPECTIVELY REPORT OUR EXPERIENCE USING THE STEALTH AUTOGUIDE, FOR FRAMELESS STEREOTACTIC BIOPSIES IN PEDIATRIC PATIENTS. METHODS: PEDIATRIC PATIENTS WHO UNDERWENT STEREOTACTIC BIOPSY USING THE STEALTH AUTOGUIDE CRANIAL ROBOTIC PLATFORM FROM JULY 2020 TO MAY 2023 WERE INCLUDED IN THIS STUDY. CLINICAL, NEURORADIOLOGICAL, SURGICAL, AND HISTOLOGICAL DATA WERE COLLECTED AND ANALYZED. RESULTS: NINETEEN PATIENTS UNDERWENT 20 PROCEDURES (MEAN AGE WAS 9-YEAR-OLD, RANGE 1¿17). IN FOUR PATIENTS, BIOPSY WAS PART OF A MORE COMPLEX SURGICAL PROCEDURE (LASER INTERSTITIAL THERMAL THERAPY ¿ LITT). THE MOST COMMON INDICATION WAS DIFFUSE INTRINSIC BRAIN STEM TUMOR, FOLLOWED BY DIFFUSE SUPRATENTORIAL TUMOR. NINE PROCEDURES WERE PERFORMED IN PRONE POSITION, EIGHT IN SUPINE POSITION, AND THREE IN LATERAL POSITION. FACIAL SURFACE REGISTRATION WAS ADOPTED IN SIX PROCEDURES, SKULL-FIXED FIDUCIALS IN 14. THE BIOPSY DIAGNOSTIC TISSUE ACQUISITION RATE WAS 100% IN THE PATIENTS WHO UNDERWENT ONLY BIOPSY, WHILE IN THE BIOPSY/LITT GROUP, ONE CASE WAS NOT DIAGNOSTIC. NO PATIENTS DEVELOPED CLINICALLY RELEVANT POSTOPERATIVE COMPLICATIONS. CONCLUSION: THE STEALTH AUTOGUIDE SYSTEM HAS PROVEN TO BE SAFE, DIAGNOSTIC, AND HIGHLY ACCURATE IN PERFORMING STEREOTACTIC BIOPSIES FOR BOTH SUPRATENTORIAL AND INFRATENTORIAL LESIONS IN THE PEDIATRIC POPULATION. REPORTED EVENT: THIS STUDY REVIEWED 20 PROCEDURES WITH 19 PATIENTS. THE MEAN AGE OF THE PATIENTS WAS 9 YEARS OLD, WITH 12 FEMALES AND 7 MALES. ONE PATIENT WAS OPERATED ON TWICE, AS AT THE FIRST BIOPSY, ONLY INFLAMMATORY CELLS WERE FOUND. DURING ANOTHER PROCEDURE, THERE WAS A MINOR INTRAPARENCHYMAL BLEEDING AT THE BIOPSY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752250 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention| H