BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILOS DR US

    MDR report key: 1972772 · Received January 21, 2011

    Report

    Report Number
    1028232-2011-00078
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 13, 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

    NO OUTPUT WAS NOTED ON TELEMETRY. TESTING SHOWED EXCELLENT VALUES FOR BOTH ATTACHED LEADS. THE PHYSICIAN REPLACED THE VENTRICULAR LEAD AND THE DEVICE WITH COMPETITIVE PRODUCTS. THE ATRIAL LEAD WAS REPOSITIONED. INTERMITTENT OVER SENSING WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR US PACEMAKER NVZ BIOTRONIK SE & CO. KG 331443

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization