BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVANOVA VNS

    MDR report key: 9335161 · Received November 18, 2019

    Report

    Report Number
    MW5091140
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    March 8, 2018
    Report Date
    November 18, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER IS REPORTING FOR HER SISTER WHO STARTED TO EXPERIENCE SEIZURES WHILE THE DEVICE WAS IMPLANTED. SHE WENT TO HAVE TWO DRS EVALUATE THE DEVICE, AND AFTER THREE TESTS THEY FOUND THE BATTERY DEPLETED PREMATURELY. IT WAS SUPPOSED TO LAST 5 YEARS BUT ONLY LASTED A YEAR AND A HALF. THE CALLER FOUND ONLINE THERE IS A CLASS ACTION LAWSUIT AGAINST THE COMPANY. SHE INFORMED THE MFR ABOUT HER SISTER'S DEVICE ISSUE, AND THE MFR REP INFORMED THE CALLER THERE WAS A RECALL ON THE DEVICE CORRELATING WITH HER SERIAL NUMBER. SHE WAS THEN CONTACTED BY THE SALES REP WHO AGGRESSIVELY TRIED TO ATTEND THE REMOVAL SURGERY, AND COLLECT THE DEVICE FOR INTERNAL EVALUATION. CALLER CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132403 LIVANOVA VNS STIMULATOR, AUTONOMIC, NERVE, IMPLANTED FOR EPILEPSY LYJ LIVANOVA USA, INC. 106

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization