BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 17117558 · Received June 13, 2023

    Report

    Report Number
    1644487-2023-00760
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 7, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750023
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 HOSPITALIZED DUE TO INCREASED SEIZURES THAT DO NOT RESPOND TO MEDICATION. THE SEIZURES WERE SUSPECTED TO BE DUE TO LOW BATTERY. THE DEVICE WAS CHECKED AND THE BATTERY WAS FOUND TO BE OK. THERE WAS NO HISTORY OR ANY TRAUMA AND THERE WERE NO CHANGES TO THE PATIENT'S MEDICATIONS PRIOR TO THE START OF THE INCREASED SEIZURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE CAUSE OF THE INCREASED SEIZURES IS DUE TO LOW BATTERY AND THE INCREASE WAS BACK TO PRE-VNS BASELINE LEVELS. NO INTERVENTION ON THE DEVICE PLANNED, OTHER THAN REPLACEMENT WHEN WE REACH NEOS. NEW MEDICATIONS / MEDICATION COMBINATIONS WERE BEING TRIED AT THE TIME TO CONTROL THE SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252505 PULSE GEN MODEL 102R GENERATOR LYJ LIVANOVA USA, INC. 102R 5162 05425025750023

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization