BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 15473667 · Received September 23, 2022

    Report

    Report Number
    1644487-2022-01177
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 30, 2022
    Report Date
    October 28, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750030
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PATIENT HAD A RETURN OF THEIR GRAND MAL SEIZURES AFTER 7 YEARS OF NOT EXPERIENCING THEM. PATIENT STATES THE VNS HAD PREVIOUSLY ABORTED THEIR SEIZURES. PATIENT STATES RECENTLY THE VNS HAS NOT BEEN ABORTING HER SEIZURES. PATIENT THINKS BATTERY IS DEPLETED, HOWEVER THE NEUROLOGIST STATED THAT THE VNS STILL HAS BATTERY REMAINING.

    Description of Event or Problem · 0

    IT WAS BY PHYSICIAN THAT THE REPORTED GRAND MAL SEIZURES ARE NOT A CHANGE IN THEIR SEIZURE PATTERN. THE PATIENT HAD THE GRAND MAL SEIZURES SINCE INFANCY, INSINUATING THAT THE CAUSE OF THE GRAND MAL SEIZURES IS THE PATIENT'S INHERENT PHYSIOLOGY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553680 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 202851 05425025750030

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other