BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR MODEL UNKNOWN

    MDR report key: 23124715 · Received September 23, 2025

    Report

    Report Number
    1644487-2025-10644
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    January 1, 2013
    Report Date
    September 23, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. IN 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. CITATION BLOCK: PI: DR. (B)(6). CO-PIS: DR. (B)(6).

    Description of Event or Problem · 0

    BASED ON A REVIEW OF SCIENTIFIC LITERATURE PUBLISHED BY DR. GRETCHEN VON ALLMEN TITLED, "MEG-DERIVED FUNCTIONAL CONNECTIVITY SIGNATURES AS PREDICTIVE BIOMARKERS FOR RESPONSE TO VAGUS NERVE STIMULATION THERAPY" IT WAS REPORTED THAT WITHIN THE STUDY GROUP 11 PATIENTS EXPERIENCED A WORSENING OF SEIZURE FREQUENCY WITH MORE THAN A 100% INCREASE COMPARED TO BASELINE (INCREASE IN SEIZURE ACTIVITY). NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217996 GENERATOR MODEL UNKNOWN GENERATOR LYJ HOUSTON GENERATOR, MODEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown