BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 19782020 · Received July 19, 2024

    Report

    Report Number
    1644487-2024-00920
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 24, 2008
    Report Date
    July 19, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RUSSO, A. (2020). EARLY IMPLANTATION AS A MAIN PREDICTOR OF RESPONSE TO VAGUS NERVE STIMULATION IN CHILDHOOD-ONSET REFRACTORY EPILEPSY. JOURNAL OF CHILD NEUROLOGY, XX(X), 1-6. DOI: 10.1177/0883073820974855 JOURNALS.SAGEPUB.COM/HOME/JCN 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

    IT WAS REPORTED FROM LITERATURE ARTICLE THAT THREE PATIENTS SWITCHED OFF THEIR VAGUS NERVE STIMULATOR BECAUSE OF INCREASED SEIZURE FREQUENCY DURING TITRATION PHASE POST IMPLANT. PATIENT AND PRODUCT INFORMATION WAS NOT REPORTED IN THE ARTICLE AND REMAINS UNKNOWN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555030 PULSE GEN MODEL UNK GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O