BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 13457222 · Received February 4, 2022

    Report

    Report Number
    2182207-2022-00197
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    December 7, 2021
    Report Date
    February 4, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MBX
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DALIC LJ, WARREN AEL, BULLUSS KJ, ET AL. DBS OF THALAMIC CENTROMEDIAN NUCLEUS FOR LENNOX-GASTAUT SYNDROME (ESTEL TRIAL). ANN NEUROL. 2021.10.1002/ANA.26280. DEEP BRAIN STIMULATION (DBS) IS AN EMERGING TREATMENT FOR PATIENTS WITH LENNOX-GASTAUT SYNDROME (LGS), WITH INCREASING OFF-LABEL USE BASED ON SMALL, OPEN-LABEL STUDIES TARGETING THE CENTRO MEDIAN NUCLEUS OF THALAMUS. ELECTRICAL STIMULATION OF THE THALAMUS IN EPILEPSY OF THE LENNOX-GASTAUT PHENOTYPE) IS THE FIRST RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CM-DBS IN A CAREFULLY CHARACTERIZED COHORT OF YOUNG ADULTS WITH LGS. WE FOUND ALMOST 60% OF STIMULATED PARTICIPANTS HAD A =50% REDUCTION IN ELECTROGRAPHIC SEIZURES COMPARED WITH NONE OF THE CONTROLS, INDICATING A THERAPEUTIC EFFECT OF CM-DBS IN PATIENTS WITH LGS. REPORTED EVENTS 1 PATIENT EXPERIENCED A STAPH-AUREUS INFECTION AFTER AN EDEMA REQUIRING HARDWARE REMOVAL. 1 PARTICIPANT HAD A DROP SEIZURE LEADING TO FACIAL LACERATION, REQUIRING STITCHES UNDER SEDATION. 1 PATIENT EXPERIENCED A SUBDURAL HEMATOMA. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316046 ACTIVA MBX MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention