BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 774662 · Received October 27, 2006

    Report

    Report Number
    1028232-2006-00224
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    October 6, 2006
    Report Date
    October 20, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SYSTEM EXPLANTED DUE TO INFECTION. OTHER DEVICES IN THIS SYSTEM ARE: LINOX SD 65/16, MDR# 1028232-06-0225. LUMOS DR-T, MDR# 1028232-06-0223.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 ICD LEAD LWS BIOTRONIK GMBH AND CO. 350973 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization