BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14073285 · Received April 11, 2022

    Report

    Report Number
    1723170-2022-00528
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    September 13, 2021
    Report Date
    April 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON SERIAL NUMBER AND IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: BENJAMIN FISHER, WAI CHEONG SOON, JOHN ONG, TIN CHAN, YASIR CHOWDHURY, JAMES HODSON, ANWEN WHITE. IS IMAGE GUIDANCE ESSENTIAL FOR EXTERNAL VENTRICULAR DRAIN INSERTION? WORLD NEUROSURG. (2021) 156:E329-E337. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.09.060 ABSTRACT: - BACKGROUND: THIS STUDY AIMED TO COMPARE THE EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENT ACCURACY AND COMPLICATION RATES, BETWEEN NE URO NAVIGATION-GUIDED, ULTRASOUND-GUIDED, AND FREEHAND TECHNIQUES IN OUR SINGLE CENTER COHORT, AND THROUGH AN ADDITIONAL META-ANALYSIS OF THE CURRENTLY AVAILABLE LITERATURE. - METHODS: A RETROSPECTIVE REVIEW OF PATIENTS WHO UNDERWENT EVD INSERTION FROM JANUARY 2016 TO APRIL 2019 WAS CONDUCTED. INFORMATION REGARDING DEMOGRAPHICS, INDICATION, EVANS INDEX, USE OF IMAGE GUIDANCE, ACCURACY OF CATHETER TIP PLACEMENT, AND PROCEDURAL COMPLICATIONS WAS EXTRACTED FROM ELECTRONIC RECORDS AND IMAGING SYSTEMS. THE ACCURACY OF THE EVD TIP PLACEMENT WAS CLASSIFIED ACCORDING TO THE KAKARLA GRADING SYSTEM INTO OPTIMAL, OR SUBOPTIMAL BASED ON ITS PROXIMITY TO THE FORAMEN OF MONRO AND INVOLVEMENT OF NONELOQUENT/ELOQUENT STRUCTURES. - RESULTS: IN TOTAL, 294 PATIENTS (MEDIAN AGE OF 54 YEARS) UNDERWENT EVD INSERTION DURING THE STUDY PERIOD. A TOTAL OF 183 CATHETERS WERE PLACED FREEHAND, 66 NEURO NAVIGATION GUIDED, AND 45 ULTRASOUND-GUIDED; THE MEAN EVANS RATIOS WERE 0.33, 0.29, AND 0.31, RESPECTIVELY. WHILST THERE WAS A TENDENCY FOR LOWER RATES OF SUBOPTIMAL PLACEMENT WERE GUIDANCE WAS USED, WITH RATES OF 10.6% AND 15.6% FOR NEURONAVIGATION- AND ULTRASOUND-GUIDANCE, RESPECTIVELY, COMPARED TO 20.8% IN FREEHAND PLACEMENT, THIS DID NOT REACH STATISTICAL SIGNIFICANCE (P [ 0.168). HOWEVER, POOLING THIS DATA WITH TWO ADDITIONAL STUDIES ON META-ANALYSIS FOUND A SIGNIFICANT REDUCTION IN THE RISK OF SUBOPTIMAL PLACEMENT FOR IMAGE-GUIDED VS. FREEHAND EVDS (ODDS RATIO: 0.50, 95% CI: 0.32E0.77, P [ 0.002). SURGEON SENIORITY AND OTHER PROCEDURE-RELATED FACTORS HAD NO SIGNIFICANT IMPACT ON EVD PLACEMENT ACCURACY OR COMPLICATIONS. -CONCLUSIONS: OUR RESULTS, POOLED WITH THOSE OF PREVIOUS STUDIES, SUGGEST IMAGE-GUIDED EVD PLACEMENT SIGNIFICANTLY REDUCED THE RATE OF SUBOPTIMALLY PLACED EVDS. WE CONCLUDE IN APPROPRIATELY SELECTED CASES THAT IMAGE GUIDED EVD INSERTIONS MAY IMPROVE ACCURACY OF CATHETER PLACEMENTS AND REDUCE ASSOCIATED COMPLICATIONS OF THE PROCEDURE. REPORTED EVENTS: 2 PATIENTS IN THE NEURONAVIGATION COHORT EXPERIENCED POST-OPERATIVE COMPLICATIONS. 10.8% OF PROCEDURES UTILIZING NEURONAVIGATION HAD SUBOPTIMAL CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403434 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention