BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS VR

    MDR report key: 822659 · Received February 27, 2007

    Report

    Report Number
    1028232-2007-00047
    Event Type
    Injury
    Date Received
    February 27, 2007
    Date of Event
    January 3, 2007
    Report Date
    February 19, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    p950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED FOR INFECTION. ALSO INCLUDED WAS: SYNOX 53/15 BP, MDR 1028232-07-0048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS VR PACEMAKER DXY BIOTRONIK GMBH AND CO. 349811 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization