BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 22749687 · Received August 8, 2025

    Report

    Report Number
    1723170-2025-02936
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 8, 2025
    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

    D10: CONCOMITANT PRODUCT: PRODUCT ID: UNKNOWN SOFTWARE, SOFTWARE VERSION #: UNKNOWN E0127: HYPOESTHESIA, HARD PALATE HYPOESTHESIA E0506: EPISTAXIS E0744: PANSINUSITIS, RHINOGENIC HYPOACUSIA F1204: PERMANENT PATIENT IMPACT F1205: TRANSIENT / TEMPORARY PATIENT IMPACT G2: THIS EVENT OCCURRED IN ITALY, SEE SECTION E. H3, H6: NO PRODUCTS WERE RETURNED TO MEDTRONIC FOR ANALYSIS. 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: DOI 10.3389/FONC.2025.1568913 SUMMARY: INTRODUCTION: RECENTLY, THE ENDOSCOPIC ENDONASAL APPROACH (EEA) HAS BEEN PROPOSED AS A POSSIBLE SURGICAL OPTION FOR BENIGN AND MALIGNANT TUMORS, LOCATED IN THE INFRATEMPORAL (ITF) AND PTERYGOPALATINE FOSSAE (PPF). THE AIM OF THIS STUDY IS TO ANALYZE THE SURGICAL OUTCOME OF THE EEA FOR THESE LESIONS, IDENTIFYING THE PREOPERATIVE FACTORS AFFECTING TUMOR RESECTION. MATERIALS AND METHODS: ALL CONSECUTIVE CASES OF PPF AND ITF TUMORS OPERATED THROUGH AN EEA HAVE BEEN RETROSPECTIVELY COLLECTED. PREO PERATIVE CLINICAL AND RADIOLOGICAL FEATURES, SURGICAL OUTCOME, COMPLICATIONS AND PATIENT FOLLOW-UP HAVE BEEN ANALYZED. A SYSTEMATIC REVIEW OF LITERATURE HAS BEEN PERFORMED. RESULTS: THE SERIES INCLUDES 100 PATIENTS (66 MALES, 66.0%, MEAN AGE: 43.7 ± 22.1). THE MOST COMMON HISTOTYPES WERE JUVENILE ANGIOFIBROMAS (36 CASES, 36.0%), MALIGNANCIES (26, 26.0%), AND CHORDOMAS (14, 14.0%). GROSS TOTAL RESECTION OF THE PPF/ITF PORTION OF THE TUMOR WAS ACHIEVED IN 88 (88.0%) PATIENTS. THE MOST COMMON COMPLICATION WAS REPRESENTED BY 10 CASES (10.0%) OF V2 HYPOESTHESIA (3 TRANSIENT). AT LOGISTIC REGRESSION, TUMOR LOCATION IN THE TEMPORO-MASSETERIC AND TUBO-PHARYNGEAL ZONES PROVED NEGATIVELY ASSOCIATED WITH THE GTR RATE (P:0.05, P 0.01). CONCLUSION: EEA IS AN EFFECTIVE AND SAFE APPROACH FOR BOTH BENIGN AND MALIGNANT TUMORS INVOLVING THE PPF AND ITF. IT IS CHARACTERIZED BY A FAVORABLE COMPLICATIONS RATE AND A QUICK PATIENTS RECOVERY. WE OBSERVED THAT THE TUMOR EXTENSIONS IN THE TEMPORO-MASSETERIC AREA AND IN THE TUBO-PHARYNGEAL SPACE WERE THE MOST RELEVANT FACTORS NEGATIVELY ASSOCIATED WITH COMPLETE TUMOR REMOVAL. REPORTED EVENTS: THE SERIES INCLUDES 100 PATIENTS (66 MALES, 66.0%, MEAN AGE: 43.7 ±22.1). COMPLICATIONS OF THE SERIES CONSISTED IN 10 (10.0%) CASES OF DE NOVO V2 HYPOESTHESIA (7 PERMANENT AND 3 TRANSIENT), 3 OF POSTOPERATIVE RHINOGENIC HYPOACUSIA (3.0%), 1 EPISTAXIS (1.0%), 1 PANSINUSITIS (1.0%), 1 PERMANENT HARD PALATE HEMI-HYPOESTHESIA (1.0%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221719 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Hospitalization| R "SEE H11...."