BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2933094 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00106
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    November 6, 2012
    Report Date
    January 8, 2013
    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

    THIS SYSTEM WAS REMOVED AND REPLACED DUE TO SEPSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32989 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization