BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17925245 · Received October 12, 2023

    Report

    Report Number
    1723170-2023-01953
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    June 22, 2023
    Report Date
    October 12, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HANAKITA, S., SHIN, M., HASEGAWA, H., SHOJIMA, M., OHARA, K., SHINYA, Y., KAWASHIMA, M., KONDO, K., SAITO, N. ENDOSCOPIC EXTENDED TRANSSPHENOIDAL SURGERY AIMING FOR RADICAL RESECTION OF SKULL BASE TUMORS INVOLVING CAVERNOUS SINUS: ASSESSMENT OF RESECTABILITY AND RISKS OF COMPLICATIONS. OPERATIVE NEUROSURGERY. 2023. 25(260¿268) DOI: 10.1227/ONS.0000000000000749 BACKGROUND AND OBJECTIVES:SURGICAL RESECTION OF TUMORS INVADING THE CAVERNOUS SINUS (CS) STILL SHOWS THERAPEUTIC CHALLENGES. FOR ¿N ONADENOMATOUS¿ SKULL BASE TUMORS INVADING IN CS, THERE WERE ONLY A FEW REPORTS SHOWING THE OUTCOMES OF RADICAL RESECTION. THEREFORE, THE OUTCOMES OF ENDOSCOPIC TRANSSPHENOIDAL SURGERY (ETS) AIMING FOR RADICAL RESECTION THUS REMAIN LARGELY UNKNOWN REGARDING RESECTABILITY AND FUNCTIONAL RESULTS OF THE CRANIAL NERVES. METHODS: WE PERFORMED ETS AIMING FOR RADICAL RESECTION IN 35 SKULL BASE TUMORS INVOLVING CS (17 CHONDROSARCOMAS, 12 CHORDOMAS, 3 MENINGIOMAS, AND 3 TRIGEMINAL SCHWANNOMAS; MEDIAN FOLLOW-UP 36.5 MONTHS RANGING FROM 12 TO 91 MONTHS). GROSS TOTAL RESECTION (GTR) IS ATTEMPTED IN ALL THE CASES FOR REAL-TIME FINDINGS FROM ELECTROPHYSIOLOGICAL MONITORING OF THE CRANIAL NERVES. WHEN THE TUMOR WAS STRONGLY ADHERENT TO THE CRANIAL NERVES OR INTERNAL CAROTID ARTERY, MAXIMUM VOLUME REDUCTION OF THE TUMOR WAS ATTEMPTED. RESULTS: GTR WAS ACHIEVED IN 28 PATIENTS (80.0%), SUBTOTAL RESECTION IN 3 (8.6%), AND PARTIAL RESECTION IN 4 (11.4%). ONE PATIENT EXPERIENCED INTERNAL CAROTID ARTERY INJURY DURING SURGERY. AFTER ETS, 15 PATIENTS SHOWED SYMPTOM IMPROVEMENT (51.7% IN ALL 29 PATIENTS WITH PREOPERATIVE CRANIAL NERVE SYMPTOMS, CNS). FOUR (11.4%) TRANSIENTLY DEVELOPED ABDUCENS NERVE PALSY, AND ONE REQUIRED REPAIR SURGERY FOR CEREBROSPINAL LEAKAGE. IN UNIVARIATE ANALYSES, EXTENSION TO THE LATERAL COMPARTMENT OF CS (P = .04) WAS SIGNIFICANTLY ASSOCIATED WITH REDUCED ACHIEVEMENT OF GTR. PREVIOUS TRANSCRANIAL SURGERY WAS ASSOCIATED WITH REDUCED POSSIBILITY OF IMPROVEMENT AND WORSENING IN CNS. ELEVEN PATIENTS UNDERWENT STEREOTACTIC RADIOSURGERY, AT A MEDIAN OF 12 MONTHS AFTER ETS. 32 PATIENTS (91.4%) DID NOT SHOW RECURRENCE AT THE FINAL FOLLOW-UP. CONCLUSION: ETS CAN ACHIEVE SUFFICIENT SURGICAL RESECTION IN MOST OF THE PATIENTS, WITH ACCEPTABLE NEUROLOGICAL COMPLICATIONS. FOR PATIENTS WITH CNS, ETS MAY OFFER THE OPPORTUNITY FOR IMPROVING CNS. WE SHOULD ALSO ALWAYS PRIORITIZE AVOIDANCE OF CRITICAL SITUATIONS BY PREVENTING INTERNAL CAROTID ARTERY INJURY. REPORTED EVENTS: ONE PATIENT REQUIRED REPAIR SURGERY FOR CEREBROSPINAL LEAKAGE FOUR (11.4%) PATIENTS TRANSIENTLY DEVELOPED ABDUCENS NERVE PALSY ONE PATIENT EXPERIENCED INTERNAL CAROTID ARTERY INJURY DURING SURGERY. 1 PATIENT HAD TRANSIENT DIABETES INSIPIDUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115555 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention