BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 23930296 · Received December 30, 2025

    Report

    Report Number
    1644487-2025-11027
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    March 28, 2022
    Report Date
    December 30, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS ASSOCIATED WITH CAPA CA-0049 REGARDING PREVIOUSLY UNREPORTED COMPLAINTS FROM BRAZIL. 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 AFTER DEVICE IMPLANTATION, THE PATIENT EXPERIENCED FREQUENT SEIZURES REQUIRING EMERGENCY MEDICATION AND OXYGEN SUPPORT; DESPITE USING THE HIGH THERAPEUTIC DOSAGE AND MULTIPLE TREATMENTS, SEIZURES REMAINED FREQUENT AND INTENSE, LEADING TO MONTHLY HOSPITALIZATIONS. IT WAS ALSO NOTED THAT THE PATIENT'S GENERATOR THAT WAS IMPLANTED DURING THE SCOPE OF THESE ADVERSE EVENTS WAS REPLACED DUE TO LOW BATTERY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258994 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205771 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Female Hospitalization| R