BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR MODEL UNKNOWN

    MDR report key: 25004392 · Received April 27, 2026

    Report

    Report Number
    1644487-2026-10519
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    November 11, 2025
    Report Date
    April 27, 2026
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BANSAL L, JAAFAR F, KAPOOR A, ABDELMOITY L, MADKOOR A, KAUFMAN C, ET AL. TRANSFORMING PEDIATRIC EPILEPSY CARE: REAL-WORLD INSIGHTS FROM A LEADING SINGLE-CENTER STUDY ON VAGUS NERVE TREATMENT OUTCOMES. EPILEPSIA. 2026; 67:762¿774. HTTPS://DOI.ORG/10.1111/EPI.70002.

    Description of Event or Problem · 0

    AN ARTICLE TITLED "TRANSFORMING PEDIATRIC EPILEPSY CARE: REAL-WORLD INSIGHTS FROM A LEADING SINGLE-CENTER STUDY ON VAGUS NERVE TREATMENT OUTCOMES" WAS IDENTIFIED TO CONTAIN POTENTIAL VNS COMPLAINTS. WITHIN THE ARTICLE IT WAS REPORTED THAT DURING THE TRIAL, VNS THERAPY WAS WELL TOLERATED, WITH MOSTLY MILD ADVERSE EVENTS; THE MOST COMMON WAS OBSTRUCTIVE SLEEP APNEA, WHICH WAS MANAGED THROUGH PARAMETER ADJUSTMENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56416 GENERATOR MODEL UNKNOWN GENERATOR LYJ HOUSTON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other