BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16410107 · Received February 21, 2023

    Report

    Report Number
    1644487-2023-00215
    Event Type
    Injury
    Date Received
    February 21, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 4, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED FOR INCREASED SEIZURES, THAT THE FAMILY BELIEVES IS DUE TO A LOW BATTERY. A BLC WAS RAN BASED ON PATIENTS SETTINGS AS OF 1/6/2023 BEING 1.5MA/20HZ/250¿S WITH A 49% DUTY CYCLE. THE RESULT REVEALED 1.1 YRS. REMAINING UNTIL NEOS = YES.

    Description of Event or Problem · 0

    PATIENT LATER HAD A BATTERY REPLACEMENT DUE TO BATTERY DEPLETION. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228908 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204819 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other