BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 VR-T

    MDR report key: 2830583 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02770
    Event Type
    Death
    Date Received
    November 5, 2012
    Date of Event
    June 7, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P980023
    Adverse Event
    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 MOL1. THE DEVICE WAS IMPLANTED FOR (B)(6) MONTHS AND 50 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE INSPECTION OF THE ICD MEMORY REVEALED NO ANOMALIES. THE AVAILABLE IEGMS SHOWED A NORMAL DEVICE BEHAVIOR WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. 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 PROVED TO BE FULLY FUNCTIONAL. THE ANALYSIS OF THE AVAILABLE IEGMS SHOWED A FLAWLESS DEVICE BEHAVIOUR WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS PATIENT EXPIRED ON (B)(6) 2012, DUE TO VENTRICULAR TACHYCARDIA, ISCHEMIC CARDIOMYOPATHY AND MYOCARDIAL INFARCTION. THE EXACT DATE THIS DEVICE WAS EXPLANTED IS UNKNOWN. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, 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 Death