BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 21337553 · Received February 7, 2025

    Report

    Report Number
    1644487-2025-00142
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    May 1, 2017
    Report Date
    February 7, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PANAH, P.Y., CANDAN, F.U., WARREN, A.E. ET AL. COMPARATIVE EFFICACY AND SAFETY OF MID-NECK VS. SUPRACLAVICULAR VAGUS NERVE STIMULATION IN PEDIATRIC DRUG-RESISTANT EPILEPSY. CHILDS NERV SYST 41, 21 (2025). HTTPS://DOI.ORG/10.1007/S00381-024-06656-6. 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

    DURING A REVIEW OF SCIENTIFIC ARTICLES REGARDING VNS THERAPY, A SCIENCE ARTICLE TITLED "COMPARATIVE EFFICACY AND SAFETY OF MID-NECK VS. SUPRACLAVICULAR VAGUS NERVE STIMULATION IN PEDIATRIC DRUG-RESISTANT EPILEPSY". THE ARTICLE WAS FOUND RESEARCHING THE INSERTION APPROACH FOR VNS SURGERY AND LISTED COMMONS SIDE EFFECTS SEEN WITH VNS. THE ARTICLE LISTED THE EVENTS OF APNEA, INFECTION, URINARY RETENTION, FATIGUE, INCREASED SEIZURES REQUIRING INTERVENTION (PROLONGED HOSPITALIZATION), DYSPNEA, INCREASED SEIZURES, MIGRATION, AND UNSPECIFIED ADVERSE EVENTS WHICH REQUIRED REVISIONS. MFR. REPORT# WILL CAPTURE THE GENERAL REPORT OF AN INCREASE IN SEIZURES. MFR. REPORT# 1644487-2025-00143 WILL CAPTURE THE OTHER LISTED ADVERSE EVENTS AND REPORT OF INCREASE IN SEIZURES REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867095 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown