BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 2882189 · Received November 13, 2012

    Report

    Report Number
    1028232-2012-02812
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON INTERROGATION, AN ERROR MESSAGE STATING ¿CONDITION 267¿ WAS DISPLAYED. DEVICE RESET WAS NOT SUCCESSFUL. THE PATIENT IS UNDERGOING RADIATION THERAPY. DEVICE EXPLANT WAS RECOMMENDED. (B)(6) 2012 ¿ WE WERE INFORMED THAT THERE ARE NO PLANS TO EXPLANT THE DEVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR PACEMAKERS NVZ BIOTRONIK SE & CO. KG 349799

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other