BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 HF-T

    MDR report key: 1211784 · Received October 24, 2008

    Report

    Report Number
    1028232-2008-01302
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 HF-T, MDR 1028232-2008-01302. SETROX S 53, MDR 1028232-2008-01303. LINOX SD 65/16, MDR 1028232-2008-01304. COROX OTW-S 85-BP, MDR 1028232-2008-01305.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 HF-T CRT-D LWS BIOTRONIK GMBH AND CO. 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization