BEUDAMED
    FDA Adverse Event Death Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 24592437 · Received March 13, 2026

    Report

    Report Number
    3004785967-2026-00153
    Event Type
    Death
    Date Received
    March 13, 2026
    Date of Event
    January 22, 2025
    Report Date
    March 13, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (BOXBOROUGH)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2 CORRECTION TO B5: ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED TO CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 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. ADDITIONAL CODING IN THE "ADDITIONAL CODING" AREA 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

    ADDITIONAL REVIEW OF THE COMPLAINT INDICATED THAT BASED ON THE PROVIDED INFORMATION AND MEDICAL EXPERTISE, THE PATIENT'S DEATH WAS DETERMINED TO BE UNRELATED TO THE NAVIGATION SYSTEM.

    Description of Event or Problem · 0

    BOUSCATEL, I., MARLIER, B., LITRÉ, CF., BATCHINSKY-PARROU, V., RIVOLLIER, M., LONIEWSKI, S., KLEIBER, J.C. EVALUATION OF FEASIBILITY ACCURACY AND SAFETY AFTER 79 O-ARM BASED STEREOTACTIC BRAIN BIOPSIES. SCIENTIFIC REPORTS. 2025. 15 (2799) HTTPS://DOI.ORG/10.1038/ S41598-025-86069-W ABSTRACT: FRAME-BASED STEREOTACTIC BRAIN BIOPSY (FSBB) IS A MINIMALLY INVASIVE PROCEDURE WITH A VIEW TO INCREASING THE DIAGNOSTIC YIELD. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE ACCURACY AND SAFETY OF FSBB WITH THE HELP OF THE INTRAOPERATIVE 3D O-ARM SYSTEM. A PREOPERATIVE MRI ALLOWED FOR TARGETING THE TISSUE TO BE SAMPLED. A LEKSELL STEREOTACTIC FRAME WAS BOLTED TO PATIENT¿S SKULL IN THE OPERATING ROOM, AND WE PROCEEDED TO THE INTRAOPERATIVE 3D O-ARM ACQUISITION. A SOFTWARE PLATFORM WAS USED TO CALCULATE STEREOTACTIC COORDINATES THROUGH COMBINING BOTH EXAMS. A SECOND 3D O-ARM ACQUISITION WAS PERFORMED TO CONTROL THE FINAL NEEDLE TARGET POINT. A TOTAL OF 79 PATIENTS WERE INCLUDED IN OUR STUDY POPULATION, 68 BIOPSIES (86.1%) YIELDED THE DIAGNOSIS. BIOPSY-RELATED COMPLICATIONS OCCURRED IN 11 PATIENTS (13.9%), OF WHOM 8 WERE SUCCESSFULLY DIAGNOSED. PER AND POST-PROCEDURE COMPLICATIONS OCCURRED IN 3 (3.8%) AND 8 CASES (10.1%) RESPECTIVELY. MEAN OPERATING TIME WAS 102 MIN. FSBB USING THE INTRAOPERATIVE 3D O-ARM SYSTEM IS A PROMISING ALTERNATIVE. THE RATE OF NON-CONTRIBUTORY BIOPSIES IS MODERATE GIVEN THAT THIS NEW PROCEDURE IS CONDUCTED IN THE OPERATING ROOM FROM BEGINNING TO END. COMPLICATIONS WERE NOT DIRECTLY LINKED TO THE PROCEDURE AND DOES NOT COMPROMISE THE DIAGNOSIS. REPORTED EVENTS ONE DEATH WAS REPORTED, RESULTING IN A MORTALITY OF 1.27%. ONE PATIENT DIED BY SEPTIC SHOCK, BECAUSE OF A MENINGITIS 18 DAYS AFTER THE BIOPSY BUT NO COMPLICATION AROSE DURING THE PROCEDURE, NOR WAS THERE ANY NEUROLOGICAL AGGRAVATION DURING THE NIGHT AT HOSPITAL FOLLOWING THE BIOPSY. THIS PATIENT HAD SUFFERED FROM A LOSS OF CONSCIOUSNESS 7 DAYS AFTER THE PROCEDURE DUE TO A KETOACIDOSIS, AND FROM FEVER APPEARED 11 DAYS THEREAFTER. BIOLOGICAL TESTS SHOWED A URINARY TRACT INFECTION. THE PATIENT FELL INTO A COMA. BLOOD CULTURE AND LUMBAR PUNCTURE THEN IDENTIFIED AN ENTEROBACTERIA BACTEREMIA AND A MENINGITIS. HE DIED TWO WEEKS AFTER THE BIOPSY. THREE OTHER PATIENTS DEVELOPED POST-OPERATIVE COMPLICATIONS INCLUDING ONE CENTRAL FACIAL PARALYSIS WITH DYSARTHRIA WHICH REGRESSED THANKS TO A CORTICOSTEROID INJECTION AND TWO GENERALIZED SEIZURES CONTROLLED THROUGH ANTIEPILEPTIC AGENTS. BIOPSY-RELATED COMPLICATIONS OCCURRED IN 11 PATIENTS (13.9%) 8 COMPLICATIONS WERE COMPLETELY RESOLVED WITH DRUG TREATMENT WHEREAS 1 COMPLICATION REQUIRED SURGERY UNDER GENERAL ANESTHESIA. CLINICAL WORSENING WAS OBSERVED DURING THE PROCEDURE FOR THREE PATIENTS, RESULTING IN A PER-PROCEDURE COMPLICATIONS RATE OF 3.8%. ALL THE PATIENTS WITH PER-PROCEDURE COMPLICATIONS UNDERWENT A CT AS AN EMERGENCY MEASURE. ONE PATIENT HAD AN EPILEPTIC PARTIAL SEIZURE WITH SECONDARY GENERALIZATION INTRAOPERATIVELY. THIS PATIENT SUFFERED FROM INTRACEREBRA L HEMATOMA ALONG THE BIOPSY TRAJECTORY, AND HE HAD NEW SEIZURES DURING HIS HOSPITAL STAY, WHICH REQUIRED THE INITIATION OF AN ANTI-EPILEPTIC TREATMENT THE TWO OTHER ONES PRESENTED WITH INTRACRANIAL HYPERTENSION POST-OPERATIVE COMPLICATIONS (8 PATIENTS, 10.1%). AMONG THEIR 8 PATIENTS, 3 POST-OPERATIVE COMPLICATIONS WERE RELATED TO NON-CONTRIBUTORY BIOPSIES BUT 5 (62.5%) WERE CONTRIBUTORY BIOPSIES AND REVEALED HIGH GRADE GLIAL TUMORS IN 4 CASES (50% OF THESE 8 BIOPSIES) WITH 1 ANAPLASTIC ASTROCYTOMA, 1 ANAPLASTIC OLIGODENDROGLIOMA AND 2 GLIOBLASTOMAS. PRE-OPERATIVE NEUROLOGIC DEFICIT WAS WORSE AFTER THE BIOPSY IN FOUR PATIENTS. A CEREBRAL CT WAS PERFORMED AND A POST-OPERATIVE CEREBRAL HEMORRHAGE WAS CONFIRMED IN THREE CASES. ONE OF THOSE PATIENTS SUFFERED FROM THE AGGRAVATION OF HIS LEFT-SIDED HEMIPARESIS DUE TO A POST-OPERATIVE HEMATOMA WITH A DISCRETE RADIOLOGICAL MASS EFFECT BUT WITH A MAJOR EDEMA. THE SECOND PATIENT SUFFERED FROM THE AGGRAVATION OF A RIGHT-SIDED HEMIPARESIS CAUSED BY A FRONTAL HEMATOMA AND THE THIRD ONE EXPERIENCED HEADACHE AND VOMITING DUE TO A POST-OPERATIVE CEREBRAL HEMATOMA. ANOTHER PATIENT SUFFERED FROM WORSENING APHASIA DUE TO A LARGE CEREBRAL EDEMA BUT WITHOUT HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318625 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