BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 2883818 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02884
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL2. THE DEVICE WAS IMPLANTED FOR 46 MONTHS AND 25 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE HEADER OF THE ICD WAS VISUALLY INSPECTED, REVEALING NO ANOMALIES. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT AND THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. THE SET SCREWS SHOWED SCREW MARKS ON THE BOTTOM SIDE INDICATING THAT THEY WERE TIGHTENED DURING THE IMPLANTATION. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE ANALYSIS OF THE AVAILABLE IEGM'S NOISE WAS OBSERVED IN THE VENTRICULAR CHANNEL. THEREFORE, A SENSING TEST WAS PERFORMED, AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD TO BE FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE DEVICE WERE TESTED. HOWEVER, THE IMPEDANCE MEASUREMENT FUNCTIONS PROVED TO BE FLAWLESS. 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 AND THE SHOCK-IMPEDANCE WAS AS EXPECTED. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO A POSSIBLE MALFUNCTION DURING DFT TESTING AND NOISE ON THE RV CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization