BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR

    MDR report key: 812361 · Received February 2, 2007

    Report

    Report Number
    1028232-2007-00021
    Event Type
    Injury
    Date Received
    February 2, 2007
    Date of Event
    October 28, 2006
    Report Date
    January 30, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION. ALSO PART OF THIS SYSTEM ARE: SELOX ST 53, MDR 1028232-07-0023, SELOX JT 45, MDR 1028232-07-0022.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR