BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 18278163 · Received December 6, 2023

    Report

    Report Number
    1644487-2023-01743
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    August 15, 2023
    Report Date
    March 19, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    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

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE CAUSE OF THE INCREASED SEIZURES AND AURAS IS UNKNOWN AND THE INCREASED SEIZURES WERE BACK TO PRE-VNS BASELINE LEVELS. THE INTERVENTION TAKEN FOR THE EVENTS WERE MEDICATION TITRATION AND A VNS REVISION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE SUSPECT DEVICE WAS DISCARDED. INTERNAL DATA WAS ALSO RECEIVED AND REVIEWED FOR THE EXPLANTED GENERATOR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT A FULL REVISION. THE FULL REVISION OCCURRED SINCE THE PATIENT HAD LEAD DAMAGE AFTER BEING IN A CAR ACCIDENT A HIGH LEAD IMPEDANCE VALUE WAS NOT OBSERVED BUT DAMAGE TO THE LEAD WAS VISUALLY OBSERVED IN SURGERY AND THE PATIENT ALSO REPORTED NOT BEING ABLE TO PERCEIVE MAGNET STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES LATELY. THEY HAD THEIR DEVICE CHECKED AND ALL VALUES WERE WITHIN NORMAL LIMITS. THE PATIENT IS BEING REFERRED FOR X-RAY IMAGES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364806 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 202281 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male