BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 10984265 · Received December 10, 2020

    Report

    Report Number
    1644487-2020-01656
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    February 8, 2019
    Report Date
    June 10, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B2: FURTHER REVIEW OF DATA FOUND THE HIGH IMPEDANCE OBSERVED WAS DUE TO THE V1.5 SOFTWARE ISSUE FOR M102/M102R GENERATORS. D1: SUSPECT DEVICE UPDATED TO MODEL 3000 PROGRAMMING SYSTEM. F10: MEDICAL DEVICE CODE: A160105 & A110204 SHOULD HAVE BEEN REPORTED AS ISSUE IS DUE TO SOFTWARE. F10: COMPONENT CODE: G02008 SHOULD HAVE BEEN REPORTED AS ISSUE IS DUE TO SOFTWARE. H6: INVESTIGATION FINDINGS: C100204 & C1202 SHOULD HAVE BEEN REPORTED AS ISSUE IS DUE TO SOFTWARE H6: INVESTIGATION CONCLUSIONS: D01 SHOULD HAVE BEEN REPORTED AS ISSUE IS DUE TO SOFTWARE VOLUNTARY MEDICAL DEVICE CORRECTION (REMEDIAL ACTION) WAS INITIATED BY THE MANUFACTURER ON 11/16/2018, AND THE PHYSICIAN WAS PROVIDED A NOTIFICATION LETTER WITH RECOMMENDED ACTIONS. H9: INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    FURTHER REVIEW OF THE PROGRAMMING DATA RECEIVED DISCOVERED THAT THE HIGH IMPEDANCE WAS OBSERVED WHEN V1.5 SOFTWARE WAS USED ON A M102 GENERATOR. SYSTEM DIAGNOSTICS WERE INITIALLY PERFORMED WHICH CAUSED THE FALSE HIGH IMPEDANCE TO BE OBSERVED. NORMAL MODE DIAGNOSTICS WERE PERFORMED SOON AFTER AND SHOWED HIGH LEAD IMPEDANCE BUT DCDC CODE 0. THE IMPEDANCE WAS LIKELY STORED FROM THE PREVIOUS SYSTEM DIAGNOSTICS. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 V1.5.2.1 SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 V1.5.2.1 SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PATIENT HAD A GENERATOR REPLACEMENT OCCUR. IMPEDANCE WAS OBSERVED TO BE WITHIN NORMAL LIMITS AFTER REPLACEMENT. THE EXPLANTED GENERATOR WAS DISCARDED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    PROGRAMMING HISTORY REVIEW WAS PERFORMED. IT WAS OBSERVED THE PATIENT HAD HIGH IMPEDANCE WHEN SYSTEM DIAGNOSTICS WERE PERFORMED ON ONE PROGRAMMING SYSTEM. NO IMPEDANCE ISSUES WERE OBSERVED WHEN A SECOND PROGRAMMING SYSTEM WAS USED. PER THE PHYSICIAN, IT WAS REPORTED THAT NO HIGH IMPEDANCE WAS OBSERVED. THE PHYSICIAN IS NOT SURE WHERE THE HIGH IMPEDANCE READING CAME FROM. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453054 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ LIVANOVA USA, INC. MODEL 3000 010093

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR