BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/18

    MDR report key: 1221856 · Received November 3, 2008

    Report

    Report Number
    1028232-2008-01298
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER REP. THIS SYSTEM WAS REMOVED DUE TO INFECTION: LUMAX 340 DR-T, MDR 1028232-2008-1297. LINOX SD 65/18, MDR 1028232-2008-01298. SETROX S 53, MDR 1028232-2008-01299.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK GMBH AND CO. 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization