BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR MODEL UNKNOWN

    MDR report key: 22729762 · Received August 6, 2025

    Report

    Report Number
    1644487-2025-10437
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    March 18, 2025
    Report Date
    July 30, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. N PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE. HOGEVEEN L, LEGROS B, MEURS A, DE HERDT V, SPRENGERS M, HÖDL S, MERTENS A, GADEYNE S, RAEDT R, DEWAELE F, VANDERSTEENE J, BOON P, VONCK K. THE EFFECTIVENESS OF CENOBAMATE IN PATIENTS TREATED WITH VAGUS NERVE STIMULATION FOR DRUG RESISTANT EPILEPSY. EUR J NEUROL. 2025 JUN;32(6):E70229. DOI: 10.1111/ENE.70229. PMID: 40536401; PMCID: PMC12178080.

    Description of Event or Problem · 0

    DURING A REVIEW OF A SCIENTIFIC ARTICLE ENTITLED, "THE EFFECTIVENESS OF CENOBAMATE (CNB) IN PATIENTS TREATED WITH VAGUS NERVE STIMULATION FOR DRUG RESISTANT EPILEPSY" SEVERAL ADVERSE EVENTS WERE DISCOVERED. UNSPECIFIED ADVERSE EVENTS RESULTING IN MEDICAL INTERVENTION WERE SEEN IN 8 PATIENTS, INTERVENTION INCLUDED EITHER DEVICE DISABLEMENT OR VNS REMOVAL BEFORE THE CNB TREATMENT DUE TO INEFFECTIVENESS OR SIDE EFFECTS, THE MOST COMMON BEING SEDATION RELATED EFFECTS. NO OTHER DETAILS WERE PROVIDED ON THE EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337499 GENERATOR MODEL UNKNOWN GENERATOR LYJ HOUSTON GENERATOR, MODEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention