BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T

    MDR report key: 2882168 · Received November 13, 2012

    Report

    Report Number
    1028232-2012-02819
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS INTERROGATED, REVEALING THE BATTERY STATUS BOL. THE DEVICE WAS IMPLANTED FOR 4 MONTHS AND 4 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE ICD AS WELL AS THE RETURNED PROGRAMMER PRINTOUTS WERE INSPECTED. THE ANALYSIS REVEALED THE PRESENCE OF NOISE IN THE FARFIELD CHANNEL, AS WELL AS IN THE PRESENTED SURFACE ECG LEADS I, II, AND III, INDICATING AN EXTERNAL INFLUENCE. THE SENSING FUNCTIONS OF THE DEVICE WERE TESTED UNDER IN VIVO CONDITIONS USING DIFFERENT TEMPERATURE ENVIRONMENTS. THE ICD SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE DEVICE TO BE FULLY FUNCTIONAL. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. DUE TO THE PRESENCE OF NOISE IN THE EXTERNAL SURFACE ECG LEADS, IT CANNOT BE EXCLUDED THAT THE PRESENCE OF INVASIVE EXTERNAL INFLUENCES, SUCH AS STRONG ELECTROMAGNETIC FIELDS MAY HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. THERE WAS NEITHER FOR THE LEAD NOR FOR THE ICD ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS REMOVED AND REPLACED BECAUSE THERE WAS NOISE ON THE SENSING CHANNEL AND THE FAR FIELD CHANNEL. AFTER TROUBLESHOOTING, THE PHYSICIAN WAS UNABLE TO DIAGNOSE THE ISSUE, SO THE DEVICE AND RV LEAD WERE BOTH REMOVED. SHOULD ADD¿L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 VR-T ICD MRM BIOTRONIK SE & CO. KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization