BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR - T

    MDR report key: 1020466 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00346
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    December 22, 2007
    Report Date
    March 7, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER MDRF, THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. A NEW SYSTEM WAS IMPLANTED ONE WEEK LATER. SETROX S 60, MDR: 1028232-2008-00347. SETROX S 53, MDR: 1028232-2008-00348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR - T PACER LEAD DTB BIOTRONIK GMBH AND CO. 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization