BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 1252387 · Received December 4, 2008

    Report

    Report Number
    1028232-2008-01573
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 VR-T, MDR 1028232-2008-01572.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization