BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 21157935 · Received January 15, 2025

    Report

    Report Number
    1644487-2025-00044
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    December 11, 2024
    Report Date
    February 6, 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
    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

    B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT, CORRECTED DATA: INITIAL REPORT INADVERTENTLY SELECTED WRONG OUTCOME. F10 HEALTH EFFECT - IMPACT CODE, CORRECTED DATA: INITIAL REPORT INADVERTENTLY OMITTED CODE F08.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HAD AN INCREASE IN SEIZURES. THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE THE PATIENT'S GENERATOR WAS INTERROGATED AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PATIENT'S GENERATOR WAS DISABLED TO ALLOW HOSPITAL STAFF TO EVALUATE THE PATIENT INDEPENDENT OF VNS STIMULATIONS. ADDITIONAL INFORMATION WAS LATER RECEIVED FROM THE PATIENT'S PHYSICIAN NOTING THE PATIENT HAS HAD AN INCREASE IN SEIZURE FREQUENCY, SEVERITY AND DURATION. PER THE PHYSICIAN, THE PATIENT WOULD ONLY AVERAGE A GRAND MAL SEIZURES ONCE PER MONTH, BUT WITHIN THE PAST DAY, BEGAN TO EXPERIENCE 5 GRAND MAL SEIZURES. ADDITIONAL INFORMATION WAS RECEIVED NOTING THE PATIENT'S DEVICE WAS LEFT OFF AFTER HER VISIT TO THE EMERGENCY ROOM, WITH PLANS FOR HER NEUROLOGIST TO RE-ENABLE THERAPY AT HER FOLLOW-UP APPOINTMENT. THE PATIENT'S SESSION REPORT WAS ALSO PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986196 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 206307 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other| H