BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS VR-T

    MDR report key: 1012609 · Received March 10, 2008

    Report

    Report Number
    1028232-2008-00250
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    August 28, 2007
    Report Date
    February 8, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER STUDY EXIT FORM, THIS SYS WAS EXPLANTED DUE TO INFECTION. ALSO REMOVED: LINOX T 65, MDR 1028232-2008-00251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS VR-T ICD LWS BIOTRONIK GMBH AND CO. 353219

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization