BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 21337542 · Received February 7, 2025

    Report

    Report Number
    1644487-2025-00141
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 7, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MALAISAMY MUNIYANDI, SIGNIFICANT REDUCTION OF SEIZURE FREQUENCY IN PATIENTS WITH DRUG-RESISTANT EPILEPSY BY VAGUS NERVE STIMULATION: SYSTEMATIC REVIEW AND META-ANALYSIS, EPILEPSY RESEARCH, VOLUME 210, 2025, 107510, ISSN 0920-1211, HTTPS://DOI.ORG/10.1016/J.EPLEPSYRES.2025.107510. 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.

    Description of Event or Problem · 0

    DURING REVIEW OF SCIENCE ARTICLE; SIGNIFICANT REDUCTION OF SEIZURE FREQUENCY IN PATIENTS WITH DRUG-RESISTANT EPILEPSY BY VAGUS NERVE STIMULATION: SYSTEMATIC REVIEW AND META-ANALYSIS, IT WAS IDENTIFIED THAT ADVERSE EVENTS OF TEMPORARY LEFT VOCAL CORD PARALYSIS AND PERMANENT LEFT VOCAL CORD PARALYSIS OCCURRED DUE TO VNS TREATMENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126139 LEAD MODEL UNKNOWN LEAD LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O