BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 14987275 · Received July 12, 2022

    Report

    Report Number
    1644487-2022-00838
    Event Type
    Injury
    Date Received
    July 12, 2022
    Date of Event
    June 13, 2022
    Report Date
    October 6, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 THAT THE PATIENT WENT TO SEE HIS DOCTOR TO HAVE SETTINGS INCREASED. EVER SINCE, STIMULATION HAS BEEN CONTINUOUS. PATIENT WENT TO HOSPITAL, WAS ADMITTED FOR 2 DAYS AND SENT HOME. NO ONE TURNED OFF HIS VNS DEVICE. CONTINUOUS STIMULATION HAS CAUSED MIGRAINES, BUZZING SENSATION IN SKULL, AND BALANCE ISSUES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    UPDATE WAS RECEIVED THAT THE GENERATOR WAS EXPLANTED AND REPLACED DUE TO BATTERY DEPLETION. THE DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293667 PULSE GEN MODEL 105 GENERATOR LYJ LIVANOVA USA, INC. 105 4033 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other| H