BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR MODEL 1000-D

    MDR report key: 22206816 · Received June 13, 2025

    Report

    Report Number
    1644487-2025-10254
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 7, 2025
    Report Date
    August 5, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750528
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    117

    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 SINCE REPLACEMENT, THE PATIENT HAS HAD A SIGNIFICANT INCREASE IN SEIZURES. THE PATIENT ALSO REPORTED THAT THEY CAN NO LONGER PERCEIVE STIMULATION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AS A RESULT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT AND PHYSICIAN DETERMINED THAT THE INCREASE IN SEIZURES WAS LIKELY A INCREASE IN STRESS FROM THE SURGERY/ANESTHESIA, AND A RESPIRATORY INFECTION SHE WAS FIGHTING AT THE TIME. THE NEURO CLASSIFIED THIS AS "NOT RELATED TO VNS". THE INCREASE IN SEIZURE RATE WAS NOTED TO BE ABOVE THEIR PRE-VNS BASELINE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569161 GENERATOR MODEL 1000-D GENERATOR LYJ HOUSTON GENERATOR, MODEL 1000-D 960 05425025750528

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization