BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 2883816 · Received November 16, 2012

    Report

    Report Number
    1028232-2012-02879
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 30, 2012
    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 LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE PHYSICIAN ATTEMPTED TO REPOSITION THIS LEAD, BUT DECIDED TO REPLACE IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization