BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 2213042 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01795
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED TO THE HOSP WITH SHORTNESS OF BREATH AND FATIGUE. A BLOOD CULTURE WAS POSITIVE FOR INFECTION AND IV ANTIBIOTICS WERE ADMINISTERED. THIS SYS WAS LATER REMOVED. SHOULD ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization