BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 23879808 · Received December 23, 2025

    Report

    Report Number
    1644487-2025-10997
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 23, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED AS THE PATIENT HAD BEEN EXPERIENCING SEIZURES FOR TWO DAYS. THE PHYSICIANS AT HOSPITAL STATE THAT THE PATIENT IS POST ICTAL BUT MOTHER BELIEVES HE IS STILL HAVING THE SEIZURE. THE DEVICE WAS UNABLE TO BE INTERROGATED DUE TO LACK OF AVAILABILITY FROM THE NEUROLOGIST. THE MOTHER ALSO REPORTS THAT IN ADDITION TO THE INCREASE IN SEIZURES CONDITION, THE PATIENT WAS NOT ABLE TO SPEAK, NOR WERE THEY ABLE TO MOVE THEIR LEGS. ASSOCIATION TO VNS THERAPY FOR THESE EVENTS HAS NOT BEEN DETERMINED TO DATE. THREE GOOD FAITH ATTEMPTS HAVE BEEN MADE TO THE PHYSICIAN FOR ADDITIONAL INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381481 LEAD MODEL 300 LEAD LYJ HOUSTON 300-20

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other| H