BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 4152155 · Received October 8, 2014

    Report

    Report Number
    1028232-2014-003553
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    April 3, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    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 MOL2. THE ICD WAS IMPLANTED FOR 54 MONTHS AND 74 CHARGING CYCLES WERE RECORDED TO THE ICD'S MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE ANALYSIS OF THE AVAILABLE IEGMS NOISE WAS OBSERVED IN THE RIGHT-VENTRICULAR AS WELL AS THE FARLFIELD-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 ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS AND 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 ICD WAS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PHYSICIAN CHOSE TO REPLACE THIS DEVICE WHILE REPLACING THE RECALLED COMPETITIVE RV LEAD DUE TO A FRACTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630421 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization