BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 1654515 · Received April 5, 2010

    Report

    Report Number
    1028232-2010-00633
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PATIENT CODED AND WAS TAKEN TO THE HOSPITAL, WHERE SHE EXPIRED THE NEXT DAY.

    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 62 YR Death