BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 HF-T

    MDR report key: 1933784 · Received December 13, 2010

    Report

    Report Number
    1028232-2010-02694
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    August 5, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT EXPIRED ON (B)(6) 2010. THE PT WAS LAST SEEN BY THE FOLLOWING PHYSICIAN ON (B)(6) 2010 AND WAS LAST SEEN IN THE HOSPITAL IN (B)(6) 2010. IT APPEARS THAT THE PT EXPERIENCED A VF STORM ON (B)(6) 2010. THE FOLLOWING PHYSICIAN'S OFFICE HAS NO COMPLAINTS ASSOCIATED WITH THIS DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death