BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 3040788 · Received April 8, 2013

    Report

    Report Number
    1028232-2013-00924
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 25, 2013
    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 INTERROGATION REVEALED THE BATTERY STATUS ERI. A NUMBER OF 24 CHARGING CYCLES WAS DOCUMENTED. 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 ICD WAS IMPLANTED FOR 43 MONTHS; 24 CHARGING CYCLES WERE DOCUMENTED IN THE ICD'S MEMORY. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. IN SUMMARY, THE ICD WAS FULLY FUNCTIONAL. THE ERI BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS DEVICE IS AT ERI INDICATION AND WAS REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144164 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization