BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYLOS DR

    MDR report key: 1012527 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00240
    Event Type
    Death
    Date Received
    March 12, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION. THE FOLLOWING PHYSICIAN'S OFFICE COULD PROVIDE NO INFORMATION REGARDING THIS DEVICE. THE PATIENT EXPIRED IN 2008 OF CARDIAC ARREST.

    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