BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS VR-T

    MDR report key: 777162 · Received November 3, 2006

    Report

    Report Number
    1028232-2006-00228
    Event Type
    Injury
    Date Received
    November 3, 2006
    Date of Event
    August 15, 2006
    Report Date
    October 26, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM EXPLANTED DUE TO INFECTION WITH KENTROX SL-S 65/16, MDR 1028232-06-0229.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS VR-T ICD LWS BIOTRONIK GMBH AND CO. 356077 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization