BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 22058020 · Received May 20, 2025

    Report

    Report Number
    1644487-2025-10155
    Event Type
    Injury
    Date Received
    May 20, 2025
    Date of Event
    January 19, 2023
    Report Date
    June 17, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT NOTE THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT D6B IF EXPLANTED, GIVE DATE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT PROVIDE THE EXPLANT DATE H6 ADVERSE EVENT PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT CODE 'F1905' FOR HEALTH EFFECT-IMPACT CODE.

    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

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE INCREASED SEIZURES AND STATUS WERE ASSESSED TO BE RELATED TO LOW BATTERY, AND THEY WERE ABOVE PRE-VNS BASELINE LEVELS. THE PATIENT UNDERWENT A BATTERY REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES, AND THEIR BATTERY WAS LATER FOUND TO BE AT NEOS (NEAR END OF SERVICE) =YES. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE SEIZURES ON (B)(6) 2023 AND HAD THEIR MEDICATION ADJUSTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INSTANCE WHERE THEY EXPERIENCED AN 8-MINUTE-LONG SEIZURE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50843 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205388 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Other| H