BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 21384080 · Received February 14, 2025

    Report

    Report Number
    1644487-2025-00165
    Event Type
    Death
    Date Received
    February 14, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 14, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LONG-TERM SEIZURE REDUCTION ASSOCIATED WITH VAGAL NERVE STIMULATION IN DRAVET SYNDROME. SUNANJAY BAJAJ1, ALINA IVANIUK2, TOBIAS BRUENGER1, ÉMILE MOURA COELHO DA SILVA1, EMILY HUTH1, LUDOVICA MONTANUCCI1, COSTIN LEU1, GARY TAYLOR1, MOUSUMI SINHA1, RAHIL A. TAI1, MANISH N. SHAH3,4, MICHAEL W. WATKINS1, JEREMY E. LANKFORD1, INDIRA M. KOMMURU1, SANDIPAN PATI1, PRAKASH KOTAGAL5, ANDREAS ALEXOPOULOS5, SAMDEN D. LHATOO1, ELIA PESTANA KNIGHT5, GRETCHEN VON ALLMEN6, DENNIS LAL. 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

    DURING A REVIEW OF SCIENTIFIC LITERATURE TITLED: LONG-TERM SEIZURE REDUCTION ASSOCIATED WITH VAGAL NERVE STIMULATION IN DRAVET SYNDROME; IT WAS REPORTED THAT A PATIENTS IMPLANTED WITH VNS EXPERIENCED RESPIRATORY COMPLICATIONS DURING AN ADMISSION FOR STATUS EPILEPTICUS- WHICH ULTIMATELY LED TO DEATH. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982407 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death