BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17030636 · Received May 31, 2023

    Report

    Report Number
    1723170-2023-00884
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    September 29, 2021
    Report Date
    May 31, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE.EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. 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

    STUART, M.J., MEHIGAN, B., COLBRAN, R.E., WITHERS, T.K., NG, E. ORTHOGONAL EXTERNAL VENTRICULAR DRAIN (EVD) TRAJECTORY FROM BURR HOLES SITED BY JUNIOR NEUROSURGICAL STAFF IS SUPERIOR TO FREEHAND PLACEMENT: AN IN-SILICO MODEL. JOURNAL OF CLINICAL NEUROSCIENCE. 2021. 94 (65-69) DOI.ORG/10.1016/J.JOCN.2021.09.041 ABSTRACT EXTERNAL VENTRICULAR DRAIN (EVD) OR VENTRICULOSTOMY PLACEMENT IS ONE OF THE MOST COMMON NEUROSURGICAL PROCEDURES PERFORMED WORLDWIDE AND IS ASSOCIATED WITH COMPLICATIONS INCLUDING HAEMORRHAGE, MALPOSITION AND INFECTION. SEVERAL AUTHORS HAVE ATTEMPTED TO DEFINE AN IDEAL TRAJECTORY FOR PLACEMENT, AND SCALP-MOUNTED GUIDANCE DEVICES HAVE BEEN DEVISED TO EXPLOIT THE THEORETICAL IDEAL ORTHOGONAL TRAJECTORY FROM THE SCALP TO THE LATERAL VENTRICLES. HOWEVER, UPTAKE HAS BEEN LIMITED DUE TO LACK OF DEMONSTRATED SUPERIORITY TO FREEHAND PLACEMENT. PREVIOUS MODELLING STUDIES HAVE FAILED TO INCLUDE A TRUE-TO-LIFE SAMPLE OF PATIENTS UNDERGOING EVD INSERTION AND EXCLUDED CASES WITH MIDLINE SHIFT OR NON-HYDROCEPHALUS INDICATIONS. FURTHER, NONE HAVE ATTEMPTED TO MODEL THE ORTHOGONAL INSERTION OF EVD VIA ACTUAL BURR HOLES PLACED BY JUNIOR NEUROSURGICAL STAFF. IN OUR REPORT OF 58 CASES OF FRONTAL EVD INSERTION IN A LOW-VOLUME AUSTRALIAN NEUROSURGICAL UNIT FREEHAND EVD INSERTION RESULTED IN ACCEPTABLE PLACEMENT IN THE IPSILATERAL FRONTAL HORN IN 62% OF CASES, ANY VENTRICLE IN 22%, AND IN ELOQUENT OR NON-ELOQUENT BRAIN IN 16% OF CASES. THE MODELLED ORTHOGONAL TRAJECTORY FROM THE SAME BURR HOLES, USING POST-PROCEDURAL COMPUTED TOMOGRAPHY SCANS AND THE S8 STEALTH STATION (MEDTRONIC), RESULTED IN SUPERIOR PLACEMENT; 80% IN THE IPSILATERAL FRONTAL HORN AND 20% CONTRALATERAL (P¿=¿0.007). THERE WERE NO SIGNIFICANT MALPOSITIONS ASSOCIATED WITH THE MODELLED TRAJECTORIES. IN OUR SERIES, 18% OF FREEHAND CATHETERS REQUIRED MULTIPLE PLACEMENT ATTEMPTS. IN CONCLUSION, OUR DATA SUGGESTS THAT AN ORTHOGONAL TRAJECTORY MAY RESULT IN IMPROVED EVD POSITIONING COMPARED TO FREEHAND PLACEMENT. REPORTABLE EVENTS: 5 CASES THERE WAS MIDLINE SHIFT IN EXCESS OF 5 MILLIMETERS 5 CASES THE BURR HOLE WAS MEDIALLY MISPOSITIONED <(><<)>28 MM FROM THE MIDLINE ONE CASE WHERE THE PATIENT HAD AN UNUSUALLY STEEP CALVARIAL SLOPE AT KOCHER'S POINT RESULTING IN AN ORTHOGONAL TRAJECTORY AT THE SKULL RESULTING IN A NONORTHOGONAL TRAJECTORY RELATIVE TO THE FRONTAL HORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682691 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female