BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 21715506 · Received March 27, 2025

    Report

    Report Number
    1644487-2025-00332
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    January 20, 2025
    Report Date
    March 27, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHAN E, MANI AR. ASSESSING THE THERAPEUTIC POTENTIAL OF VAGUS NERVE STIMULATION IN AUTOIMMUNE DISEASES: A SYSTEMATIC REVIEW. PHYSIOL REP. 2025 FEB;13(3):E70230. DOI: 10.14814/PHY2.70230. PMID: 39903575; PMCID: PMC11793006. 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 HAVE NOT 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. H3. DEVICE EVALUATED BY MFR? CODE 81 - DEVICE EVALUATION IS NOT NECESSARY BECAUSE THE REPORTED EVENT HAS BEEN DETERMINED TO BE RELATED TO THE IMPLANT PROCEDURE.

    Description of Event or Problem · 0

    DURING REVIEW OF THE SCIENCE ARTICLE TITLED ""ASSESSING THE THERAPEUTIC POTENTIAL OF VAGUS NERVE STIMULATION IN AUTOIMMUNE DISEASES: A SYSTEMATIC REVIEW", IT WAS REPORTED THAT ADVERSE EVENTS WERE EXPERIENCED WITH THE VNS PATIENTS. THE ARTICLE COMPRISED OF 19 STUDIES IN WHICH REPORTS INFECTION WERE IDENTIFIED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2415782 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other