BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 22544269 · Received July 18, 2025

    Report

    Report Number
    3004785967-2025-00502
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    September 1, 2021
    Report Date
    July 18, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H3: NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE NOTED IN THE ARTICLE FOR PROCEDURES REVIEWED. B.5. INCLUDES THE ARTICLE CITATION. G.2. 510K # IS UNAVAILABLE AS THE SYSTEM INFORMATION IS 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

    PATEL, AJAY, ET AL. ¿FRAMELESS STEREOTACTIC BIOPSY OF BRAINSTEM TUMORS USING THE STEALTH AUTOGUIDE: A TECHNICAL NOTE.¿ OPERATIVE NEUROSURGERY, 20 AUG. 2024, HTTPS://DOI.ORG/10.1227/ONS.0000000000001314. ACCESSED 15 JULY 2025. BACKGROUND AND OBJECTIVES: IN THE MOLECULAR ERA OF NEURO-ONCOLOGY, IT IS INCREASINGLY NECESSARY TO OBTAIN TISSUE FOR NEXT-GENERATION SEQUENCING AND METHYLOME PROFILE FOR PROGNOSIS AND TARGETED ONCOLOGICAL MANAGEMENT. BRAINSTEM TUMORS CAN BE TECHNICALLY CHALLENGING TO BIOPSY IN THE PEDIATRIC POPULATION. FRAME-BASED AND FRAMELESS TECHNIQUES HAVE PREVIOUSLY BEEN DESCRIBED AND PROVEN TO BE SAFE AND EFFICACIOUS IN CHILDREN. RECENT CRANIAL ROBOTIC GUIDANCE PLATFORMS HAVE AUGMENTED THE FLUENCY OF FRAMELESS STEREOTACTIC APPROACHES, BUT THE TECHNICAL NUANCES OF THESE PROCEDURES IN CHILDREN ARE NOT OFTEN DISCUSSED. WE PRESENT A TECHNICAL WORKFLOW FOR FRAMELESS STEREOTACTIC BIOPSY OF BRAINSTEM TUMORS IN CHILDREN USING THE MEDTRONIC STEALTH AUTOGUIDE CRANIAL ROBOTIC GUIDANCE PLATFORM AND EXAMINE SAFETY AND EFFICACY OF THIS SURGICAL APPROACH. METHODS: A MINIMALLY INVASIVE, FRAMELESS, TRANSCEREBELLAR APPROACH IS DESCRIBED, INCLUDING OPERATIVE STEPS AND WORKFLOW. WE ASSESSED OPERATIVE TIMES, DIAGNOSTIC ACCURACY AND YIELD, AND COMPLICATION RATES. RESULTS: FIVE PATIENTS UNDERWENT BIOPSY WITH THE TECHNIQUE DESCRIBED. THE YOUNGEST PATIENT IN OUR SERIES WAS OF 2 YEARS. THE INTENDED TARGET WAS ACHIEVED ON POSTOPERATIVE IMAGING IN ALL CASES, AND DIAGNOSTIC TISSUE WAS OBTAINED IN ALL 5 PATIENTS. ONE PATIENT HAD A CLINICALLY INSIGNIFICANT HEMORRHAGE. CONCLUSION: FRAMELESS STEREOTACTIC BIOPSY OF THE BRAINSTEM CAN BE PERFORMED SAFELY, EFFICIENTLY, AND ACCURATELY USING THE MEDTRONIC STEALTH AUTOGUIDE ROBOTIC PLATFORM IN CHILDREN AS YOUNG AS 2 YEARS. 1. "ONE PATIENT HAD A CLINICALLY INSIGNIFICANT HEMORRHAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196603 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC. (BOXBOROUGH) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Other