BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 2052475 · Received March 15, 2011

    Report

    Report Number
    1028232-2011-00578
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 2, 2011
    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

    THIS DEVICE EXHIBITED TOTAL LOSS OF CAPTURE AFTER RE-INITIALIZATION. IT WAS REPLACED WITH ANOTHER BIOTRONIK PACEMAKER.

    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 73 YR Hospitalization