BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS DR-T

    MDR report key: 1151391 · Received September 4, 2008

    Report

    Report Number
    1028232-2008-01065
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE. THIS DEVICE AND TWO COMPETITOR'S LEADS WERE REMOVED, DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS DR-T LWS BIOTRONIK GMBH AND CO 353220

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization