BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22131918 · Received June 3, 2025

    Report

    Report Number
    1644487-2025-10201
    Event Type
    Death
    Date Received
    June 3, 2025
    Date of Event
    May 5, 2025
    Report Date
    September 20, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    H6, ADVERSE EVENT PROBLEM CODES, CORRECTED DATA: PRIOR SUPPLEMENTAL REPORT INADVERTENTLY SUBMITTED WITHOUT CORRESPONDING INVESTIGATION FINDINGS CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    FURTHER INFORMATION RECEIVED THAT, PER THE PHYSICIAN, THE PATIENT'S DEATH WAS NOT RELATED TO VNS IN ANY WAY. PER THE PHYSICIAN, THE EXACT CAUSE OF DEATH IS UNKNOWN, AND THE PATIENT WAS ON HOSPICE CARE AND PASSED AWAY PEACEFULLY AT HOME. THE VNS SYSTEM WAS NOT EXPLANTED AFTER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064482 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 7337 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Death