BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 11642097 · Received April 9, 2021

    Report

    Report Number
    1644487-2021-00486
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    November 28, 2020
    Report Date
    April 9, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ARTICLE TITLED "THE EFFECTS OF CORONAVIRUS DISEASE 2019 (COVID-19) PANDEMIC ON PEOPLE WITH EPILEPSY (PWE): AN ONLINE SURVEY-BASED STUDY" WAS RECEIVED. THE ARTICLE DISCUSSES THE EFFECTS OF COVID-19 ON PEOPLE WITH EPILEPSY. THERE WERE 5 PATIENTS IN THE STUDY WHO HAD A VNS DEVICE. IT WAS INDICATED THAT THESE PATIENT'S EXPERIENCED AN INCREASE IN SEIZURES DURING THIS TIME. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537455 PULSE GEN MODEL UNK GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1