BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17049834 · Received June 2, 2023

    Report

    Report Number
    1644487-2023-00707
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 2, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 IS REQUESTING A FOLLOW UP VISIT WITH THEIR NEURO DUE TO UNEXPLAINED SUDDEN SYMPTOMS OF INCREASED SEIZURES AND OTHER NON SERIOUS ADVERSE EVENTS. THE PATIENT WAS PREVIOUSLY SEIZURE FREE AND WAS NOT EXPERIENCING ANY OF THESE SYMPTOMS PRIOR (NOT RECENTLY). NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971999 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 7438 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female