BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD, MODEL UNKNOWN

    MDR report key: 21753816 · Received April 2, 2025

    Report

    Report Number
    1644487-2025-00362
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    January 1, 2004
    Report Date
    April 2, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ZWOLINSKA E, BIRSKI M, HOPPE S, PACZKOWSKI D, HARAT M. LONG-TERM EFFICACY AND QUALITY-OF-LIFE CHANGES AFTER VAGUS NERVE STIMULATION IN ADULT PATIENTS WITH DRUG-RESISTANT EPILEPSY. J CLIN NEUROL. 2025 MAR;21(2):113-122. DOI: 10.3988/JCN.2024.0218. PMID: 40065452; PMCID: PMC11896742. 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

    AN ARTICLE ENTITLED "LONG-TERM EFFICACY AND QUALITY-OF-LIFE CHANGES AFTER VAGUS NERVE STIMULATION IN ADULT PATIENTS WITH DRUG-RESISTANT EPILEPSY" WAS REVIEWED BY THE MANUFACTURER . THE ARTICLE MONITORED SEIZURE FREQUENCY RATES AND INTENSITY OF 55 PATIENTS IMPLANTED WITH VNS. THE FOLLOWING ADVERSE EVENTS/MALFUNCTIONS WERE REPORTED IN THE STUDY: INCREASE IN SEIZURES, CHANGE IN SEIZURE PATTERN (INCREASED SEIZURE DURATION) AND LEAD FRACTURE AMONG OTHER NON REPORTABLE EVENT. THIS REPORT WILL CAPTURE THE MALFUNCTIONS REPORTED WITHIN THE ARTICLE. MFR REP# 1644487-2025-00363 CAPTURES THE ADVERSE EVENTS REPORTED WITHIN THE SAME ARTICLE. ATTEMPTS FOR ADDITIONAL INFORMATION WAS MADE TO THE CONTRIBUTOR OF THE ARTICLE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687158 LEAD, MODEL UNKNOWN LEAD LYJ CYBERONICS - HOUSTON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown