BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 1902834 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02374
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP, ATTEMPTS TO INTERROGATE THIS DEVICE WERE UNSUCCESSFUL. NO MAGNET RATE WAS OBSERVED WITH THIS DEVICE. THE DEVICE WAS CONFIRMED TO BE A BIOTRONIK DEVICE VIA THE X-RAY ID MARKER. NO PACING WAS OBSERVED. THIS PT WAS KNOWN TO HAVE BEEN RECEIVING THERAPEUTIC RADIATION TREATMENTS. THE DEVICE WAS EXPLANTED AND RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization