BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 18866002 · Received March 8, 2024

    Report

    Report Number
    1644487-2024-00264
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    June 19, 2020
    Report Date
    April 5, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    F10. ADVERSE EVENT PROBLEM; CORRECTED INFORMATION ; INITIAL MDR INADVERTENTLY INCLUDED INCORRECT INFORMATION IN INITIAL MDR.

    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. HEALTH EFFECT - CLINICAL CODE :E233001 HEALTH EFFECT - CLINICAL CODE :E010901 HEALTH EFFECT - CLINICAL CODE :E060101

    Description of Event or Problem · 0

    DURING A REVIEW OF AN ARTICLE TITLED "COMPLETE HEART BLOCK AND VENTRICULAR ASYSTOLE CAUSED BY VAGUS NERVE STIMULATION THERAPY" AN EVENT INVOLVING A VNS PATIENT EXPERIENCING BRADYCARDIA AND COMPLETE ATRIOVENTRICULAR NODE BLOCK IN ASSOCIATION WITH VNS STIMULATION WAS REPORTED IN AN UNKNOWN VNS PATIENT. THE PATIENT WAS HOSPITALIZED DUE TO THIS ARRHYTHMIA, DYSPNEA AND DIZZINESS. THE PATIENT ALSO REPORTED PAIN AT THEIR CHEST. THE VNS WAS DISABLED AND THE BRADYCARDIA WAS NOTED TO BE RESOLVED. THE PATIENT ALSO REPORTED AN INCREASE IN SEIZURES AFTER THIS SETTINGS ADJUSTMENT. THE ARTICLE WAS UNABLE TO IDENTIFY THE EXACT MECHANISM OF THE REPORTED BRADYARRHYTHMIA. THE PATIENT NOR HEALTHCARE PROFESSIONALS INVOLVED WERE NOT IDENTIFIED, MAKING FOLLOW UP ON THIS EVENT IMPOSSIBLE NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196031 PULSE GEN MODEL UNK GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Hospitalization| R