BEUDAMED
    FDA Adverse Event Death Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 24234885 · Received February 2, 2026

    Report

    Report Number
    3004785967-2026-00066
    Event Type
    Death
    Date Received
    February 2, 2026
    Date of Event
    September 12, 2025
    Report Date
    April 23, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3) THE MEDICAL SAFETY TEAM REVIEWED THE CASE AND FOUND THAT THE REPORTED HARMS WERE NOT RELATED TO THE O-ARM DEVICE AND ARE KNOWN I NHERENT SURGICAL RISKS ASSOCIATED WITH ALL STEREOTACTIC BIOPSY PROCEDURES. TWO DIFFERENT INTRAOPERATIVE IMAGING MODALITIES WERE USED AND NEITHER WERE REPORTED BY THE AUTHORS AS BEING RELATED TO THE REPORTED INHERENT PROCEDURAL COMPLICATIONS. THE AUTHOR'S DESCRIPTION STATED THAT "NO TECHNICAL FAILURE LEADING TO THE BIOPSY ARREST OCCURRED.". 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.

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. 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.

    Additional Manufacturer Narrative · 0

    H2) MEDTRONIC MEDICAL SAFETY REVIEWED THIS CASE DURING THE COMPLAINT HANDLING INVESTIGATION PROCESS, AND IT WAS DETERMINED THAT THIS EVENT DOES NOT MEET THE REPORTABILITY CRITERIA, AS THE REPORTED PATIENT DEATHS WERE UNRELATED TO THE O-ARM IMAGING SYSTEM. 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

    SCHUMACHER, X., HUDELIST, B., PAUN, L., BENZAKOUN, J., DEMASI, M., HAMZA, M., ROUX, A., MOIRAGHI, A., ELIA, A., PARRAGA, E., DEZAMIS, E., CHRETIEN, F., VARLET, P., OPPENHEIM, C., PALLUD, J., ZANELLO, M. PREVALENCE AND RISK FACTORS OF NONYIELD BRAIN BIOPSY: A 21-YEAR EXPERIENCE WITH ROBOT-ASSISTED STEREOTACTIC BIOPSIES. JOURNAL OF NEUROSURGERY. 2025. 143(6):1490-1500. DOI: 10.3171/2025.2. JNS242273. OBJECTIVE: MAGNETIC RESONANCE IMAGING-BASED, ROBOT-ASSISTED STEREOTACTIC BRAIN BIOPSY IS INCREASINGLY USED WORLDWIDE. HOWEVER, LARGE SERIES REPORTING NONYIELD BIOPSY RATES OF ROBOT-ASSISTED BIOPSIES ARE LACKING IN THE LITERATURE. THE AIM OF THIS STUDY WAS TO REPORT A 21-YEAR-LONG EXPERIENCE ON MRI-BASED, ROBOT-ASSISTED STEREOTACTIC BIOPSY FOR BRAIN LESIONS. METHODS: THE RECORDS FROM A SINGLE-CENTER, RETROSPECTIVE, AND CONSECUTIVE COLLECTION OF ALL ADULT PATIENTS UNDERGOING MRI-BASED, ROB OT-ASSISTED STEREOTACTIC BIOPSY FOR A BRAIN LESION IN A TERTIARY NEUROSURGICAL CENTER FROM DECEMBER 2002 TO JANUARY 2024 WERE REVIEWED. RESULTS: A TOTAL OF 911 PATIENTS (377 FEMALES, MEAN AGE AT SURGERY 61.1 ± 16.7 YEARS) WERE INCLUDED. OF THESE PATIENTS, 15 (1.6%) HAD A NONYIELD BIOPSY. THE NONYIELD BIOPSY RATE REMAINED STABLE OVER THE 21-YEAR-LONG STUDY PERIOD (P = 0.224). THE NONYIELD BIOPSY RATE WAS SIGNIFICANTLY HIGHER FOR NEUROLOGICAL DISEASES (4/19, 21.5%) THAN INFECTIOUS DISEASES (1/20, 5.0%) AND TUMORS (10/872, 1.1%) (P <(><<)> 0.001). THERE WERE SIGNIFICANTLY MORE NONYIELD BIOPSIES FOR DEEP-SEATED LESIONS (8/261, 3.1%) THAN FOR SUPERFICIAL LESIONS (6/612, 1.0%) (P = 0.025) AND NON-CONTRAST-ENHANCED LESIONS (6/99, 6.1%) THAN IN CONTRAST-ENHANCED LESIONS (9/797, 1.1%) (P <(><<)> 0.001). PATIENTS IN THE NONYIELD BIOPSY GROUP HAD SIGNIFICANTLY SMALLER LESIONS ON BOTH CONTRAST-ENHANCED 3D T1-WEIGHTED SEQUENCES (1.9 ± 2.2 VS 27.1 ± 29.5 CM3, P = 0.046) AND FLAIR SEQUENCES (14.0 ± 17.0 VS 80.7 ± 73.3 CM3, P <(><<)> 0.001). PREOPERATIVE CORTICOSTEROID ADMINISTRATION (407/911, 44.7%; WITH THE BIAS THAT CORTICOSTEROIDS WERE AVOIDED IN PATIENTS WITH SUSPECTED LYMPHOMA), NUMBER OF BIOPSY SAMPLES (MEAN 4.9 ± 2.4), NEUROSURGEON EXPERIENCE, AND WHO CLASSIFICATION VERSIONS WERE NOT ASSOCIATED WITH A HIGHER RISK OF NONYIELD BIOPSY (P = 0.274, P = 0.053, P = 0.968, AND P = 0.366, RESPECTIVELY). CONCLUSIONS: MRI-BASED, ROBOT-ASSISTED STEREOTACTIC BIOPSY LED TO A LOW RATE OF NONYIELD BIOPSY. NEUROLOGICAL DISEASE, NON-CONTRAST-ENHANCED LESIONS, AND DEEP-SEATED LESIONS WERE MORE AT RISK OF NONYIELD BIOPSY. REPORTABLE EVENTS: 93 POST-OPERATIVE HEMORRHAGES 104 POST-OPERATIVE SEIZURES 206 POST-OPERATIVE COMPLICATIONS 8 POST-OPERATIVE HEMATOMA REQUIRING SURGICAL EVACUATION 86 NEW/WORSENING OF NEUROLOGICAL DEFICIT 58 INTRAOPERATIVE BLEEDING 52 PERMANENT NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292813 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 61 YR Male Required Intervention| D