BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 1841558 · Received September 17, 2010

    Report

    Report Number
    1028232-2010-01904
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 17, 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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM BIOTRONIK REPRESENTATIVE (B)(4). PER OOS, THIS DEVICE EXHIBITED INTERMITTENT CAPTURE AND OUTPUT. THE DEVICE AND ASSOCIATED VENTRICULAR LEAD (SJM 1488TC-46, (B)(4)) WERE EXPLANTED. A NEW CYLOS DR, (B)(4), WAS SUCCESSFULLY IMPLANTED.

    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 91 YR Hospitalization