BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 9648459 · Received January 30, 2020

    Report

    Report Number
    1644487-2020-00144
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 19, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750443
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE VERSION: (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOW OUTPUT CURRENT MESSAGE RECEIVED. IT WAS REPORTED THAT THE PATIENT'S OUTPUT CURRENT AND MAGNET CURRENT HAD TO BE LOWERED IN ORDER FOR THE LOW OUTPUT CURRENT MESSAGE NOT TO APPEAR. INTERNAL DATA OF THE GENERATOR WAS REVIEWED AND INDICATED THAT THE GENERATOR WAS PROGRAMMED OFF AND THEN PROGRAMMED BACK ON. A SYSTEM DIAGNOSTIC TEST WAS NOT RECORDED WITHIN THE AVAILABLE INTERNAL DATA OF THE GENERATOR. 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
    110844 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. 3000 05425025750443

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR