BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR-T

    MDR report key: 789064 · Received November 29, 2006

    Report

    Report Number
    1028232-2006-00267
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 21, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE SYSTEM WAS EXPLANTED DUE TO HEMATOMA AND POSSIBLY INFECTION. SETROX S 45, MDR 1028232-06-0268. SETROX S 53, MDR 1028232-06-0270.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization