BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7

    MDR report key: 11268820 · Received February 2, 2021

    Report

    Report Number
    1723170-2021-00280
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    May 4, 2017
    Report Date
    February 23, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO ADVERSE EVENT MENTIONED WITHIN THE ARTICLE WAS DIRECTLY RELATED TO MEDTRONIC DE VICES/PRODUCTS.

    Additional Manufacturer Narrative · 1

    AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. WEIGHT: PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT AVAILABLE AT THE TIME OF REPORTING. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT AVAILABLE AT THE TIME OF REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CATAPANO, G., SGULO, F. G., SENECA, V., LEPORE, G., COLUMBANO, L., NUZZO, G., FLUORESCEIN-GUIDED SURGERY FOR HIGH-GRADE GLIOMA RESECTION: AN INTRAOPERATIVE ¿CONTRAST-ENHANCER¿. WORLD NEUROSURGERY. 2017. 104:239-247. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.05.022. BACKGROUND: FLUORESCEIN SODIUM SALT IS WIDELY USED IN MEDICINE AS FLUORESCEIN ISOTHIOCYANATE AND COMMONLY NAMED FLUORESCEIN (FL). THIS FLUOROPHORE HAS BEEN USED AS A FLUORESCENT TRACER FOR MANY APPLICATIONS, ESPECIALLY IN OPHTHALMIC SURGERY. IT WAS INITIALLY USED IN NEURO-ONCOLOGY IN 1948 TO CONTROL TUMOR RESECTION MARGINS. AFTER A TRANSIENT DISUSE, IT HAS RECENTLY HAD A SECOND SPRING WITH THE DEVELOPMENT OF DEDICATED FILTERS FOR OPERATING MICROSCOPES, ALTHOUGH IT IS STILL UNDER EVALUATION IN CLINICAL USE. THE AIM OF THIS STUDY IS TO CONTRIBUTE TO THE INVESTIGATION ACCORDING TO WHICH FL-GUIDED SURGERY FOR HIGH-GRADE GLIOMA (HGG) IS RELATED TO BETTER RATES OF GROSS TOTAL RESECTION (GTR) AND SO TO A BETTER OUTCOME. METHODS: WE RETROSPECTIVELY ANALYZED 23 CASES OF PATIENTS WITH NEW DIAGNOSIS OF HGG, OPERATED ON IN OUR UNIT BY INTRAOPERATIVE FL USE WITH A FILTER SYSTEM DIRECTLY INTEGRATED INTO AN OPERATIVE MICROSCOPE (GROUP 1). FLUORESCENCE WAS COMPARED WITH HISTOLOGY BY BIOPSIES CARRIED OUT BOTH IN THE FLUORESCENT AREAS AND IN THE PERIPHERY OF FLUORESCENT AREAS. GROUP 1 WAS MATCHED WITH A CONTROL GROUP OF 25 PATIENTS WITH HGG OPERATED ON IN OUR UNIT DURING THE LAST 2 YEARS WITHOUT FL GUIDANCE (GROUP 2). RESULTS: NO SIDE EFFECTS OCCURRED RELATED TO FL. HISTOLOGY AND INTRAOPERATIVE NEURONAVIGATION SHOWED STRONG CORRESPONDENCE WITH FLUORESCENT AND NONFLUORESCENT AREAS. GTR RATE WAS SIGNIFICANTLY HIGHER IN GROUP 1 (82.6%) THAN IN GROUP 2 (52%). CONCLUSIONS: INTRAOPERATIVE FLUORESCEIN-GUIDED SURGERY SHOWED SAFETY AND FEASIBILITY. OUR AND OTHER STUDIES SUGGEST AN IMPROVEMENT OF GTR RATE IN HGG THAN NONUSE. REPORTED EVENTS: ONE CASE OF CEREBELLAR GLIOBLASTOMA MULTIFORME IN GROUP 1 IN WHICH A CEREBROSPINAL FLUID FISTULA OCCURRED AND WAS RESOLVED AFTER AN ENDOSCOPIC THIRD VENTRICULOSTOMY FOR OBSTRUCTIVE HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165642 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other