BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 24116446 · Received January 20, 2026

    Report

    Report Number
    1723170-2026-00108
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    April 30, 2024
    Report Date
    April 14, 2026
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) THE MEDICAL SAFETY REVIEW WAS COMPLETED. THE SOURCE OF THIS COMPLAINT IS A PUBLICATION BY KHAN ET AL. DESCRIBING A COHORT STUDY AIMED AT EVALUATING THE FEASIBILITY, EFFECTIVENESS, AND SAFETY OF USING ELECTROMAGNETIC IMAGE-GUIDED NAVIGATION (IGN) WITH THE STEALTHSTATION S8 SYSTEM IN POSTERIOR ORBITAL TUMOR SURGERY, COMPARING OUTCOMES TO CASES PERFORMED WITHOUT IGN. SIX CASES (THREE BIOPSY AND THREE RESECTION CASES) REQUIRED REVISION SURGERY (MAJOR). BOTH THE PATIENT WITH POST-OP STRABISMUS REQUIRING NON-IGN SURGERY AND THE PATIENT WITH PERMANENT VISION LOSS WERE IN THE NON-IGN COHORT, AND THEREFORE NOT APPLICABLE TO THIS ASSESSMENT. PRESENTING DIAGNOSIS OF POSTERIOR ORBITAL TUMOR, AND INHERENT SURGICAL RISK ASSOCIATED WITH OPERATING IN THE CONFINED POSTERIOR ORBIT, INCLUDING POTENTIAL INJURY TO THE OPTIC NERVE, CRANIAL NERVES, AND EXTRAOCULAR MUSCLES, AS WELL AS POSSIBLE WORSENING OF PREEXISTING VISION OR NERVE DEFICITS. BASED ON THE EVENT DESCRIPTION AND MEDICAL EXPERTISE, THE HARM(S) OF SURGICAL COMPLICATIONS WERE ASSESSED AS NOT RELATED TO THE DEVICE, AS REASONABLY DETERMINED BY THE ABSENCE OF ANY ALLEGATIONS OF DEVICE FAILURE, MALFUNCTION, OR INACCURACY. THE STEALTHSTATION S8 SYSTEM WAS REPORTED TO FUNCTION AS INTENDED, WITH SUCCESSFUL SETUP AND REGISTRATION IN ALL CASES. THEREFORE, THE OBSERVED HARMS ARE MORE LIKELY ATTRIBUTABLE TO THE INHERENT RISKS OF POSTERIOR ORBITAL TUMOR SURGERY RATHER THAN THE DEVICE ITSELF. BASED ON THE MEDICAL SAFETY ASSESSMENT OF THIS EVENT, NO FURTHER ACTION IS RECOMMENDED. IF ADDITIONAL INFORMATION IS RECEIVED, PLEASE NOTIFY MEDICAL SAFETY FOR REASSESSMENT. 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. 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

    KHAN, R. I., GOLAHMADI, A. K., KILLEEN, R. P., O' BRIEN, D. F., MURPHY, C. IMAGE-GUIDED NAVIGATION IN POSTERIOR ORBITAL TUMOUR SURGERY: A COMPARATIVE COHORT STUDY. ORBIT. 2024. 43(5):566-575. DOI: 10.1080/01676830.2024.2343299. PURPOSE: THE POSTERIOR ORBIT IS A CONFINED SPACE, HARBOURING NEUROVASCULAR STRUCTURES, FREQUENTLY DISTORTED BY TUMOURS. IMAGE-GUIDED NAVIGATION (IGN) HAS THE POTENTIAL TO ALLOW ACCURATE LOCALISATION OF THESE LESIONS AND STRUCTURES, REDUCING COLLATERAL DAMAGE WHILST ACHIEVING SURGICAL OBJECTIVES. METHODS: WE ASSESSED THE FEASIBILITY, EFFECTIVENESS AND SAFETY OF USING AN ELECTROMAGNETIC IGN FOR POSTERIOR ORBITAL TUMOUR SURGERY VIA A COMPARATIVE COHORT STUDY. OUTCOMES FROM CASES PERFORMED WITH IGN WERE COMPARED WITH A RETROSPECTIVE COHORT OF SIMILAR CASES PERFORMED WITHOUT IGN, PRESENTING A DESCRIPTIVE AND STATISTICAL COMPARATIVE ANALYSIS. RESULTS: BOTH GROUPS WERE SIMILAR IN MEAN AGE, GENDER AND TUMOUR CHARACTERISTICS. IGN SET-UP AND REGISTRATION WERE CONSISTENTLY ACHIEVED WITHOUT SIGNIFICANT WORKFLOW DISRUPTION. IN THE IGN GROUP, FEWER LATERAL ORBITOTOMIES (6.7% IGN, 46% NON-IGN), AND MORE TRANSCUTANEOUS LID AND TRANSCONJUNCTIVAL INCISIONS (93% IGN, 53% NON-IGN) WERE PERFORMED (P = .009). THE SURGICAL OBJECTIVE WAS ACHIEVED IN 100% OF IGN CASES, WITH NO NEED FOR REVISION SURGERY (VS 23% REVISION SURGERY IN NON-IGN, P = .005). THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN SURGICAL COMPLICATIONS. CONCLUSION: THE USE OF IGN WAS FEASIBLE AND INTEGRATED INTO THE ORBITAL SURGERY WORKFLOW TO ACHIEVE SURGICAL OBJECTIVES MORE CONSISTENTLY AND ALLOWED THE USE OF MINIMAL ACCESS APPROACHES. FUTURE MULTICENTRE COMPARATIVE STUDIES ARE NEEDED TO EXPLORE THE POTENTIAL OF THIS TECHNOLOGY FURTHER. REPORTED EVENTS THE SURGICAL GOAL WAS RESECTION IN 12 CASES AND DIAGNOSTIC BIOPSY IN 14 CASES. SIX CASES REQUIRED REVISION SURGERY DUE TO FAILURE OF THE SURGICAL GOAL. NON-IGN - ONE PATIENT SUFFERED PERMANENT TOTAL VISUAL LOSS POST-OPERATIVELY ONE PATIENT SUFFERED FROM POST-OP STRABISMUS REQUIRING SURGERY IN NON-IGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532334 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention