BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 19730415 · Received July 12, 2024

    Report

    Report Number
    1644487-2024-00877
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    October 9, 2023
    Report Date
    July 12, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    DURING A LITERATURE REVIEW, AN ARTICLE DISCUSSING SLEEP AROUSAL CONFUSION ASSOCIATED WITH THE VNS WAS REVIEWED. THE PATIENT WAS SET TO THE FOLLOWING SETTINGS: 1.25MA/20HZ/30SEC/3MIN AND FURTHER TITRATION WAS NOT TOLERATED. THE PATIENT UNDERWENT A DIAGNOSTIC POLYSOMNOGRAPHY (PSG) WHICH SHOWED BURSTS OF SPIKE WAVE DISCHARGES LASTING SEVERAL SECONDS CONCERNING FOR POSSIBLE SEIZURES AS WELL AS AIRFLOW LIMITATION. SEVERAL AREAS WERE CONCERNING FOR OBSTRUCTIVE HYPOPNEAS, RHYTHMIC, APPROXIMATELY 30 SECONDS APART; HOWEVER, FURTHER EVALUATION OF THE PSG REVEALED THESE EPISODES CORRESPONDED WITH HER VNS SETTINGS. THESE WERE PRESENT BOTH DURING AWAKE AND SLEEP PERIODS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315153 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other