BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 1661283 · Received April 12, 2010

    Report

    Report Number
    1028232-2010-00954
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 8, 2010
    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

    SON CALLED TO INFORM BIOTRONIK THAT HIS FATHER PASSED AWAY ON (B) (6) 2010. THE DEVICE WAS EXPLANTED AND IS IN THE POSSESSION OF THE PRIMARY CARE PHYSICIAN. A QUESTION AROSE AS TO WHETHER THE DEVICE FUNCTIONED APPROPRIATELY ON THE DATE THE PATIENT EXPIRED. REQUESTED DEVICE RETURN.

    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 59 YR Death