BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 1952663 · Received January 3, 2011

    Report

    Report Number
    1028232-2010-02874
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 18, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL 1. THE DEVICE WAS IMPLANTED FOR 34 MONTHS AND 38 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE HEADER OF THE ICD WAS VISUAL INSPECTED, REVEALING NO ANOMALIES. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT, 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 MFG PROBLEM. NEXT, 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. 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. THE ANALYSIS REVEALED NO INDICATION OF A DEVICE MALFUNCTION. THE ICD PROVED TO BE FULLY FUNCTIONAL DURING ANALYSIS. NO INDICATIONS OF A ICD MALFUNCTION HAVE BEEN FOUND. NEITHER THE ANALYSIS OF THE LEAD NOR THE ANALYSIS OF THE ICD REVEALED ANY SIGN OF A MATERIAL OR MFG PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THIS DEVICE WAS EXPLANTED DUE TO INAPPROPRIATE SHOCK AFTER BEING IMPLANTED FOR ABOUT 34 MONTHS.

    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 UNK Hospitalization