BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 19789280 · Received July 21, 2024

    Report

    Report Number
    1644487-2024-00928
    Event Type
    Malfunction
    Date Received
    July 21, 2024
    Date of Event
    July 1, 1993
    Report Date
    August 16, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10 RELATED REPORT NUMBERS, CORRECTED DATA: INITIAL REPORT INADVERTENTLY LEFT BLANK.

    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 THE EFFECTIVENESS OF THE VNS IN PATIENTS WITH DEVELOPMENTAL AND EPILEPTIC ENCEPHALOPATHIES REVEALED THAT, MOST SIDE EFFECTS WERE MILD AND IMPROVED OVER TIME AND FOLLOWING ADJUSTMENT OF STIMULATION PARAMETERS. THE EVENTS INCLUDE VOICE ALTERATION, DYSPNEA, INCREASED SEIZURES, LEAD FRACTURE, INFECTION, SLEEP DISTURBANCES AND DYSPEPSIA (ABDOMINAL PROBLEMS). MFR. REPORT# 1644487-2024-00928 CAPTURES THE LEAD FRACTURE MFR. REPORT# 1644487-2024-00929 CAPTURES THE VOICE ALTERATIONS, DYSPNEA, INCREASED SEIZURES, DYSPEPSIA, INFECTION AND SLEEP DISTURBANCES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738311 LEAD MODEL UNKNOWN LEAD LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown