BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMOS DR-T

    MDR report key: 916822 · Received September 18, 2007

    Report

    Report Number
    1028232-2007-00335
    Event Type
    Death
    Date Received
    September 18, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS REPORTED TO HAVE EXPIRED IN 2007. IT IS NOT KNOWN AT THIS TIME IF THE PATIENT DEATH IS DEVICE RELATED. WE ARE NOW INQUIRING ABOUT THE RETURN OF THE DEVICE FOR ANALYSIS. RAM DUMP OF THIS DEVICE IS ADDED PER THE ATTACHED FILE. THE FAMILY AND PHYSICIAN'S INTENTIONS DO NOT INCLUDE THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS DR-T LWS BIOTRONIK, INC. 353220

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death