BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 300 DR-T

    MDR report key: 1231652 · Received November 14, 2008

    Report

    Report Number
    1028232-2008-01448
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    August 25, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 300 DR-T, MDR 1028232-2008-01448. SETROX S 45, MDR 1028232-2008-01449. LINOX TD 65/16, MDR 1028232-2008-01451.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 300 DR-T ICD MRM BIOTRONIK GMBH & CO. 355266

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization