BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2172062 · Received July 18, 2011

    Report

    Report Number
    1028232-2011-01564
    Event Type
    Death
    Date Received
    July 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT EXPIRED AT HOME (B)(6) 2011. THE CAUSE OF DEATH IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death