BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 12414101 · Received September 2, 2021

    Report

    Report Number
    1644487-2021-01240
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 10, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE GENERATOR WAS REPLACED. NO ISSUES WERE NOTED WITH PRE-OP SYSTEM DIAGNOSTIC TESTING. THE EXPLANTED GENERATOR WAS DISCARDED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CLINIC NOTES THAT THE PATIENT HAS HAD BREAK THROUGH SEIZURES SINCE MAY AND HER VNS BATTERY IS LOW. IT WAS NOTED THAT SYSTEM DIAGNOSTICS WERE PERFORMED AND SETTINGS WERE KEPT THE SAME. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309848 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 202364

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention