BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 14624627 · Received June 7, 2022

    Report

    Report Number
    1644487-2022-00670
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 13, 2022
    Report Date
    January 10, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    FOLLOWING AN INCREASE IN SEIZURES, THE PATIENT¿S DEVICE WAS CHECKED AND IT WAS SEEN THAT THE PARAMETERS WERE RESET WITH AN OUTPUT CURRENT AT 0MA. IT WAS NOTED THAT THE PATIENT DID NOT HAVE AN MRI TO TURN DEVICE OFF. THE PATIENT HAS A MODEL 102 DEVICE WHICH BASED ON THE DESIGN OF THE DEVICE CAN RESET SETTINGS UPON INTERRUPTED SYSTEM DIAGNOSTIC TESTING. IN THIS CASE, IT IS MOST LIKELY THAT THE CAUSE OF THE DEVICE SETTING TO 0MA IS DUE TO A PREVIOUS SYSTEM DIAGNOSTIC TEST BEING PERFORMED, BEING INTERRUPTED AND UNINTENTIONALLY CHANGING SETTINGS TO INTENDED VALUES. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320377 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. MODEL 250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown