BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2081393 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00935
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 12, 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

    THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT, AND REPLACED.

    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 61 YR Hospitalization