BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1221847 · Received November 3, 2008

    Report

    Report Number
    1028232-2008-01312
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION. LUMAX 340 VR-T, MDR 1028232-2008-01312 LINOX SD 65/18, MDR 1028232-2008-01313.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD LWS BIOTRONIK GMBH AND CO. 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization