BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14043200 · Received April 7, 2022

    Report

    Report Number
    1723170-2022-00510
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 7, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_COMP, SERIAL/LOT #: UNKNOWN UNK_NAV_COMP REPRESENTS THE STEALTHVIZ AND STEREOTACTIC PLANNING CRANIAL SOFTWARE. PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    FENOY, A. J., SCHULZ, P. E., SANCHES, M., SELVARAJ, S., BURROWS, C. L., ASIR, B., CONNER, C. R., QUEVEDO, J., <(>&<)>AMP; SOARES, J. C. (2022). DEEP BRAIN STIMULATION OF THE ¿MEDIAL FOREBRAIN BUNDLE¿: SUSTAINED EFFICACY OF ANTIDEPRESSANT EFFECT OVER YEARS. MOLECULAR PSYCHIATRY. HTTPS://DOI.ORG/10.1038/S41380-022-01504-Y SUMMARY: DEEP BRAIN STIMULATION (DBS) TO THE SUPEROLATERAL BRANCH OF THE MEDIAL FOREBRAIN BUNDLE (MFB) HAS EMERGED AS A QUITE EFFICACIOUS THERAPY FOR TREATMENT RESISTANT DEPRESSION (TRD), LEADING TO RAPID ANTIDEPRESSANT EFFECTS. IN THIS STUDY, WE COMPLETE OUR ASSESSMENT OF OUR FIRST 10 ENROLLED PATIENTS THROUGHOUT ONE YEAR POST-IMPLANTATION, SHOWING SUSTAINED ANTIDEPRESSANT EFFECT UP TO 5 YEARS. THE PRIMARY OUTCOME MEASURE WAS A 50% REDUCTION IN MONTGOMERY-ÅSBERG DEPRESSION RATING SCALE (MADRS) SCORE, WHICH WAS INTERPRETED AS A RESPONSE. DETERMINISTIC FIBER TRACKING WAS USED TO INDIVIDUALLY MAP THE TARGET AREA. AN INSERTIONAL EFFECT WAS SEEN DURING THE 4-WEEK SHAM STIMULATION PHASE (29% MEAN MADRS REDUCTION, P = 0.02). HOWEVER, AFTER 2 WEEKS OF INITIATING STIMULATION, FIVE PATIENTS MET RESPONSE CRITERIA (47% MEAN MADRS REDUCTION, P <(><<)> 0.001). ONE PATIENT WITHDREW FROM STUDY PARTICIPATION AT 6 WEEKS. TWELVE WEEKS AFTER INITIATING STIMULATION, SIX OF NINE REMAINING PATIENTS HAD A >50% DECREASE IN MADRS SCORES RELATIVE TO BASELINE (52% MEAN MADRS REDUCTION, P = 0.001); THESE SAME SIX PATIENTS CONTINUED TO MEET RESPONSE CRITERIA AT 52 WEEKS (63% OVERALL MEAN MADRS REDUCTION, P <(> <<)> 0.001). FOUR OF FIVE PATIENTS WHO ACHIEVED THE 5-YEAR TIME POINT ANALYSIS CONTINUED TO BE RESPONDERS (81% MEAN MADRS REDUCT ION, P <(><<)> 0.001). EVALUATION OF MODULATED FIBER TRACTS REVEALS SIGNIFICANT COMMON PREFRONTAL/ ORBITOFRONTAL CONNECTIVITY TO THE TARGET REGION IN ALL RESPONDERS. KEY POINTS LEARNED FROM THIS STUDY THAT WE CAN INCORPORATE IN FUTURE PROTOCOLS TO BETTER ELUCIDATE THE EFFECT OF THIS THERAPY ARE A LONGER BLINDED SHAM STIMULATION PHASE AND USE OF SCHEDULED DISCONTINUATION CONCOMITANT WITH FUNCTIONAL IMAGING. REPORTED EVENTS: TEN PATIENTS WITH A HISTOLOGY OF MAJOR DEPRESSIVE DISORDER UNDERWENT A DBS PROCEDURE. POST OPERATIVELY, ONE PATIENT ,OVER TIME, BECAME INCREASINGLY CONSUMED BY THEIR BODY DYSMORPHIA. THE PATIENT FELT IT WAS DUE TO THE DBS, SO JUST AFTER TWO YEARS THEY REQUESTED THAT THE SYSTEM BE REMOVED. PLEASE ADDRESS THE ARTICLE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696273 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other