BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 14718572 · Received June 16, 2022

    Report

    Report Number
    1644487-2022-00719
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 12, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LIVANOVA39S 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 HAS HAD AN INCREASE IN SEIZURES WITH OVER 63 SEIZURES. IT WAS STATED THAT THE VNS DID NOT STOP THE SEIZURES LIKE IT HAD BEFORE AND THE PATIENT CAN NO LONGER FEEL THE VNS WORKING LIFE HE DID. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THIS IS A NEW PATIENT WHOSE VNS WAS TURNED ON FOR THE FIRST TIME LESS THAN A WEEK BEFORE THIS EVENT. IT IS BELIEVED TO BE DUE TO PATIENT CONDITION. THE SEIZURES ARE BACK TO PRE-VNS BASELINE LEVELS. THEY DID INCREASE THE OUTPUT CURRENT ON THE VNS. THE MAGNET WAS NOTED TO BE NOT EFFECTIVE SINCE IT IS ONLY AT 0.5 MA AND NOT OPTIMIZED YET. SYSTEMS DIAGNOSTICS ARE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795734 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male