BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12564380 · Received October 1, 2021

    Report

    Report Number
    1723170-2021-02413
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    March 3, 2021
    Report Date
    October 1, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. PMA/510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, 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 · 1

    MATHON, B., CLEMENCEAU, S., CARPENTIER, A. INTRAOPERATIVE ULTRASOUND SHEAR-WAVE ELASTOGRAPHY IN FOCAL CORTICAL DYSPLASIA SURGERY. JOURNAL OF CLINICAL MEDICINE. 2021. 10 (1049). HTTPS://DOI.ORG/10.3390/JCM10051049 ABSTRACT: PREVIOUS STUDIES REPORTED INTEREST IN INTRAOPERATIVE SHEAR-WAVE ELASTOGRAPHY (SWE) GUIDANCE FOR BRAIN-TUMOR AND EPILEPSY S URGERIES. FOCAL CORTICAL DYSPLASIA (FCD) SURGERY IS ONE OF THE MOST APPROPRIATE INDICATIONS FOR USING SWE GUIDANCE. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF ULTRASOUND SWE TECHNIQUES FOR THE INTRAOPERATIVE DETECTION OF FCDS. WE RETROSPECTIVELY ANALYZED DATA FROM 18 ADULT PATIENTS WITH DRUG-RESISTANT EPILEPSY ASSOCIATED WITH FCD WHO HAD UNDERGONE SWE-GUIDED SURGERY. CONVENTIONAL B-MODE IMAGES DETECTED FCD IN 2 PATIENTS (11.1%), WHILE SWE DETECTED FCD IN 14 PATIENTS (77.8%). THE STIFFNESS RATIOS BETWEEN MRI-POSITIVE AND -NEGATIVE CASES WERE SIGNIFICANTLY DIFFERENT (3.6 ± 0.4 VS. 2.2 ± 0.6, RESPECTIVELY; P <(><<)> 0.001). FCDS WERE SIGNIFICANTLY MORE FREQUENTLY DETECTED BY INTEROPERATIVE SWE IN WOMEN (OR 4.7, 95% CI (1.7¿12.7); P = 0.004) AND IN PATIENTS IN WHOM FCD WAS VISIBLE ON MAGNETIC RESONANCE IMAGING (MRI; OR 2.3, 95% CI (1.3¿4.3); P = 0.04). AT 1 YEAR AFTER SURGERY AND AT LAST FOLLOW-UP (MEAN = 21 MONTHS), SEIZURE OUTCOME WAS GOOD (INTERNATIONAL LEAGUE AGAINST EPILEPSY (ILAE) CLASS 1 OR 2) IN 72.2% AND 55.6% OF PATIENTS, RESPECTIVELY. DESPITE SOME LIMITATIONS, OUR STUDY HIGHLIGHTED THE POTENTIAL OF SWE AS AN INTRAOPERATIVE TOOL TO DETECT FCD. FUTURE TECHNICAL DEVELOPMENTS SHOULD ALLOW FOR OPTIMIZING INTRAOPERATIVE SURGICAL-CAVITY EVALUATION FROM THE PERSPECTIVE OF COMPLETE FCD R ESECTION. INTEROBSERVER RELIABILITY OF SWE MEASUREMENTS SHOULD ALSO BE ASSESSED BY FURTHER STUDIES REPORTABLE INCIDENTS THREE PATIENTS EXPERIENCED TRANSIENT MOTOR OR SENSITIVE POSTOPERATIVE DEFICIT THAT FULLY RECOVERED IN WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460904 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other