BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18047651 · Received November 1, 2023

    Report

    Report Number
    1723170-2023-02112
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    June 3, 2022
    Report Date
    November 1, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    DEOPUJARI, C., SHROFF, K., KARMARKAR, V., MOHANTY, C. NEUROENDOSCOPY IN THE MANAGEMENT OF PINEAL REGION TUMOURS IN CHILDREN. CHILD'S NERVOUS SYSTEM. 2023. 39(2353¿2365) HTTPS://DOI.ORG/10.1007/S00381-022-05561-0 INTRODUCTION: PINEAL REGION TUMOURS (PRTS) ARE MORE COMMON IN CHILDREN AND REPRESENT A WIDE VARIETY OF LESIONS. THE PRACTISE OF A RADIATION TEST DOSE IS OBSOLETE AND A BIOCHEMICAL/HISTOLOGICAL DIAGNOSIS IS RECOMMENDED BEFORE FURTHER THERAPY. MANY PATIENTS PRESENT WITH HYDROCEPHALUS. ADVANCES IN NEUROENDOSCOPIC TECHNIQUES HAVE ALLOWED SAFE AND EFFECTIVE MANAGEMENT OF THIS OBSTRUCTIVE HYDROCEPHALUS WITH AN OPPORTUNITY TO SAMPLE CEREBROSPINAL FLUID (CSF) AND OBTAIN TISSUE FOR HISTOPA-THOLOGY. DEFINITIVE SURGERY IS REQUIRED IN LESS THAN A THIRD. ENDOSCOPIC VISUALISATION AND ASSISTANCE IS INCREASINGLY USED FOR RADICAL RESECTION, WHERE INDICATED. METHODOLOGY: OUR EXPERIENCE OF ENDOSCOPIC SURGERY FOR PAEDIATRIC PRTS FROM 2002 TO 2021 IS PRESENTED. ALL PATIENTS UNDERWENT MRI WITH CONTRAST. SERUM TUMOUR MARKERS WERE CHECKED. IF NEGATIVE, ENDOSCOPIC BIOPSY AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) WERE PERFORMED; AND CSF COLLECTED FOR TUMOUR MARKERS AND ABNORMAL CELLS. FOR RADICAL SURGERY, ENDOSCOPE-ASSISTED MICROSURGERY PROCEDURES WERE PERFORMED TO MINIMISE RETRACTION, VISUALISE THE EXTENT OF RESECTION AND CONFIRM HAEMOSTASIS. RESULTS: M:F RATIO WAS 2:1. THE MEDIAN AGE OF PRESENTATION WAS 11 YEARS. RAISED ICP (88.88%) WAS THE COMMONEST MODE OF PRESENTATION. NINETEEN PATIENTS HAD PINEAL TUMOURS, ONE HAD A SUPRASELLAR AND PINEAL TUMOUR, ONE HAD DISSEMINATED DIS-EASE, WHILE SIX HAD TECTAL TUMOURS. THE ETB DIAGNOSIS RATE WAS 95.45%, ACCURACY RATE WAS 83.3% AND ETV SUCCESS RATE WAS 86.96%. CONCLUSION: NEUROENDOSCOPY HAS REVOLUTIONISED THE MANAGEMENT OF PAEDIATRIC PRTS. IT IS A SAFE AND EFFECTIVE PROCEDURE WITH GOOD DIAG NOSTIC YIELD AND ALLOWS SUCCESSFUL CONCURRENT CSF DIVERSION, THEREBY AVOIDING MAJOR SURGERIES AND SHUNT IMPLANTATION. IT IS ALSO HELPFUL IN RADICAL RESECTION OF LESIONS, WHERE INDICATED. REPORTED EVENTS: -ONE PATIENT IN THE SERIES HAD TO UNDERGO CONVERSION FROM AN ENDOSCOPIC TO AN OPEN PROCEDURE IN VIEW OF SIGNIFICANT INTRA-OPERATIVE BLEEDING AFTER ETB. THIS PATIENT ALSO DEVELOPED A PSEUDOMENINGOCOELE WITH PERSISTENT HYDROCEPHALUS -ANOTHER PATIENT DEVELOPED TRANSIENT UPGAZE RESTRICTION WHICH IMPROVED OVER A FEW WEEKS. -ONE PATIENT WHO UNDERWENT ENDOSCOPIC ASSISTED MICRO-SURGERY FOR A PINEAL EPIDERMOID DEVELOPED ASEPTIC MENINGITIS AND UNDERWENT A VP SHUNT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091843 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention