BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 9279036 · Received November 5, 2019

    Report

    Report Number
    1644487-2019-02136
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 5, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON A VNS FORUM THAT THEIR VNS DEVICE WAS REMOVED WITHIN A YEAR OF BEING IMPLANTED DUE TO IT CAUSING THEM CHEST PAIN AND CAUSING DAMAGE TO THEIR VAGAL NERVE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077278 PULSE GEN MODEL UNK GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention