BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 18676036 · Received February 9, 2024

    Report

    Report Number
    1644487-2024-00124
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 16, 2024
    Report Date
    April 1, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 THE PATIENT UNDERWENT A SLEEP STUDY AND PER THE SLEEP SPECIALIST THE PATIENT WAS EXPERIENCING APNEA TRIGGERED BY VNS STIMULATION. THE NEUROLOGIST NOTED THAT THE WITH THEIR CURRENT DAY/NIGHT PROGRAMMING, IT DID SUGGEST THAT THE VNS CORRELATED TO THE APNEA. THE NEUROLOGIST'S PLAN WAS TO ADJUST THE PATIENT'S DAY/NIGHT SETTINGS AND WOULD MONITOR THE PATIENT MOVING FORWARD. THE PATIENT WAS SEEN IN CLINIC AND THE NIGHTTIME SETTINGS FOR THE NORMAL OUTPUT CURRENT WAS LOWERED TO 1MA. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51044 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 815 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other