BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR-T

    MDR report key: 1163054 · Received September 12, 2008

    Report

    Report Number
    1028232-2008-01108
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    July 9, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS SYSTEM WAS REMOVED DUE TO POCKET EROSION AND WAS REPLACED WITH ANOTHER BIOTRONIK SYSTEM. SYSTEM REMOVED: CYLOS DR-T, MDR 1028232-2008-01108. SETROX S 45, MDR 1028232-2008-01109. SETROX S 53, MDR 1028232-2008-01110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR-T PACEMAKER DXY BIOTRONIK GMBH AND CO., 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization