BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2384114 · Received December 16, 2011

    Report

    Report Number
    1028232-2011-03000
    Event Type
    Injury
    Date Received
    December 16, 2011
    Date of Event
    November 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    BIOTRONIK SE & CO., KAG
    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 DUE TO BLOOD INFECTION. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization