BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 22176874 · Received June 10, 2025

    Report

    Report Number
    1644487-2025-10238
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    April 4, 2019
    Report Date
    June 10, 2025
    Manufacturer
    HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750139
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LATER REPORTED THAT THE PATIENT CONTINUES TO HAVE NECK AND CHEST COMFORT ASSOCIATED WITH VNS STIMULATION. THE IMPEDANCE WAS NOTED TO BE WITHIN NORMAL LIMITS. MAGNET STIM WAS DISABLED IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR EXPLANT DUE TO DISCOMFORT IN THE NECK AND GENERATOR SITE. THE PHYSICIAN REPORTED THAT ONLY THE LEAD IS BEING EXPLANTED. THIS SURGERY WAS NOTED TO BE INDICATED FOR BOTH PATIENT COMFORT AND PRECLUDING A SERIOUS INJURY. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633698 LEAD MODEL 304 LEAD LYJ HOUSTON LEAD, 2.0 MM 202205 05425025750139

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention