BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15901386 · Received December 2, 2022

    Report

    Report Number
    1644487-2022-01537
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 10, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT IS HAVING INCREASE IN SEIZURES AND EXPERIENCED ONE GRAND MAL TYPE OF SEIZURE. SYSTEM DIAGNOSTICS ARE REPORTED WITHIN NORMAL LIMITS, BATTERY IS AT IFI. MEDICATION ADJUSTMENTS WERE MADE AND THE PATIENT HAS BEEN REFERRED FOR BATTERY CHANGE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANT FACILITY HAS REPORTED THAT THE DEVICE WAS DISCARDED UPON REMOVAL. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PATIENT HAD BATTERY REPLACEMENT SURGERY. FURTHER INFORMATION WAS RECEIVED FROM THE PHYSICIAN INDICATING THAT THE INCREASED SEIZURES AND NEW SEIZURE TYPE (GRAND MAL) ARE BOTH DUE TO LOW BATTERY. THE SEIZURE LEVEL ROSE TO ABOVE PRE-VNS BASELINE LEVELS. IN A PREVIOUS INVESTIGATION OF PATIENTS EXHIBITING SYMPTOMS TYPICALLY ASSOCIATED WITH GENERATOR END-OF-SERVICE (EOS/EOS (PULSE DISABLED)) PRIOR TO ACTUAL/CONFIRMED ERI (ELECTIVE REPLACEMENT INDICATOR), NEOS, EOS OR EOS (PULSE DISABLED), POSSIBLE CAUSES FOR THE ADVERSE EVENTS IDENTIFIED FROM THE INVESTIGATION INCLUDE WORSENING DISEASE STATE, UNKNOWN PHYSIOLOGICAL CHANGES IN THE BODY, OR ACCLIMATION TO THERAPY. THIS EVENT MEETS THE FINDINGS OF THIS PREVIOUS INVESTIGATION. 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
    2574125 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205293 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Required Intervention