BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 10426258 · Received August 19, 2020

    Report

    Report Number
    1644487-2020-01092
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 19, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750535
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY MEDICAL DEVICE CORRECTION (REMEDIAL ACTION) WAS INITIATED BY THE MANUFACTURER ON 2/4/2020, AND THE PHYSICIAN WAS PROVIDED A NOTIFICATION LETTER WITH RECOMMENDED ACTIONS. INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "CURRENT NOT DELIVERED" ERROR MESSAGE WAS RECEIVED WHEN PROGRAMMING THE PATIENT'S SETTINGS BACK ON AFTER BEING DISABLED FOR A MRI. THE MESSAGE RESOLVED AFTER SYSTEM DIAGNOSTICS WERE PERFORMED. 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. BASED ON THE REPORTED PROGRAMMING SEQUENCE THAT OCCURRED THAT DAY, IT WAS CONSISTENT WITH THE FALSE LOW OUTPUT CURRENT MECHANISM DESCRIBED ABOVE. THEREFORE, THE PATIENT'S GENERATOR IS EXPECTED TO BE ABLE TO DELIVER THERAPY AS PROGRAMMED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891813 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. 3000 05425025750535

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR