BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEXTROX S 53

    MDR report key: 1972771 · Received January 21, 2011

    Report

    Report Number
    1028232-2011-00084
    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. INTERMITTENT OVERSENSING WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEXTROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization