BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 19848762 · Received July 28, 2024

    Report

    Report Number
    1644487-2024-00961
    Event Type
    Injury
    Date Received
    July 28, 2024
    Date of Event
    April 1, 2015
    Report Date
    July 28, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    REVIEW OF A SCIENTIFIC ARTICLE ABOUT BI-LEVEL VNS THERAPY WITH DIFFERENT THERAPY MODES AT NIGHT AND DAYTIME REVEALED A SEVERE SLEEP-APNEA SYNDROME. IN PATIENTS WITH CONVENTIONAL VNS THERAPY SYSTEMS, WITHOUT ADDITIONAL AUTOSTIMULATION, THE INDUCTION OF NEW-ONSET DAYTIME SLEEPINESS, SNORING OR APNEA WAS SUSPECTED IN ABOUT 5% OF PATIENTS BASED ON CLINICAL INFORMATION PROVIDED BY THE PATIENTS THEMSELVES OR THEIR PARTNERS. IN PATIENTS USING VNS THERAPY WITH AUTOSTIMULATION, SYMPTOMS OF SLEEP DISORDERED BREATHING ARE REPORTED MORE FREQUENTLY, IN UP TO APPROXIMATELY 10% OF THESE PATIENTS, HOWEVER THIS HAS NOT BEEN ASSESSED SYSTEMATICALLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015171 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other