BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 9548404 · Received January 3, 2020

    Report

    Report Number
    1644487-2020-00009
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 3, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750443
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TURNED OFF A PATIENT'S GENERATOR BEFORE AN MRI AND WHEN HE TURNED IT BACK ON, THE PROGRAMMED CURRENT WAS NOT BEING DELIVERED. THIS IS CONSISTENT WITH A FALSE "LOW OUTPUT CURRENT" MESSAGE SEEN IN (B)(4) SOFTWARE. HOWEVER, THE SOFTWARE VERSION WAS NOT CONFIRMED. IT WAS REPORTED THAT THE MESSAGE WAS SEEN MULTIPLE TIMES. AS THIS MESSAGE CAN OCCUR REPEATEDLY UNTIL THE SESSION IS EXITED, IT IS UNCLEAR IF THIS HAPPENED MULTIPLE TIMES ON THE SAME PATIENT OR FOR ANOTHER PATIENT. A REPORT FOR THE EVENT THAT THIS IS IN REFERENCE TO ANOTHER PATIENT WILL BE SUBMITTED UNDER MANUFACTURING REPORT #1644487-2020-00019. INTERNAL TESTING AND DATA REVIEW IDENTIFIED THAT FALSE LOW OUTPUT CURRENT MESSAGES CAN OCCUR WHEN M3000 (B)(4) SOFTWARE PROGRAMS A M103-106 GENERATOR AFTER A SPECIFIC PROGRAMMING SEQUENCE OCCURS. WHEN M3000 (B)(4) TABLETS INITIATE A PROGRAMMING SESSION WITH A M103-106 GENERATOR, WHERE ITS OUTPUT CURRENT IS PROGRAMMED OFF (0 MA), AND THEN THE OUTPUT CURRENT IS PROGRAMMED BACK ON TO >0 MA, A LOW OUTPUT CURRENT MESSAGE WOULD BE SEEN WHEN AN IN-SESSION INTERROGATION IS PERFORMED. THIS WOULD PERSIST UPON MULTIPLE IN-SESSION INTERROGATIONS AND IF DIAGNOSTICS WEREN'T PERFORMED DURING THE SESSION, SHOW ON THE SESSION REPORT. RUNNING SYSTEM DIAGNOSTICS OR ENDING AND RESTARTING THE SESSION WILL CONFIRM FUNCTIONALITY OF THE DEVICE, AND RESOLVE THE ¿OUTPUT CURRENT LOW¿ ERROR MESSAGE. THE LOW OUTPUT CURRENT MESSAGES IN THESE CASES ARE FALSE AND DO NOT IMPACT GENERATOR FUNCTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9787 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. 3000 05425025750443

    Patients

    Seq Age Sex Outcome Treatment
    1