BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 HF-T

    MDR report key: 1780943 · Received July 29, 2010

    Report

    Report Number
    1028232-2010-01688
    Event Type
    Death
    Date Received
    July 29, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LUMAX 540 HF-T DEVICE ON (B) (6)2009. HE HAD A SERIES OF VF EPISODES TODAY, AND WAS DELIVERED 29 SHOCKS BY THE DEVICE. ONCE THE AMBULANCE CAME, HE WAS ALSO GIVEN THREE EXTERNAL SHOCKS. THE PATIENT EXPIRED. WHEN THEY TRIED TO REINTERROGATE THE DEVICE AFTERWARDS, THE DEVICE WAS AT END OF LIFE. THERE IS NO COMPLAINT AGAINST THE DEVICE. ON 7/29/2010, THIS DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 HF-T CRT-D MRM BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death