BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR

    MDR report key: 1060919 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00640
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. THE EXPLANTED SYSTEM: CYLOS DR, MDR 1028232-2008-00640. SETROX S 53, MDR 10028232-2008-00642. SELOX ST 60, MDR 1028232-2008-00641.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR PACEMAKER DXY BIOTRONIK GMBH AND CO. 349799

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization