BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2091482 · Received May 6, 2011

    Report

    Report Number
    1028232-2011-01036
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    January 9, 2011
    Report Date
    April 27, 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

    WE WERE INFORMED THAT THERE WAS A PERFORATION OF THE HEART DUE TO THE PACEMAKER LEADS. THE SYSTEM WAS REMOVED BECAUSE OF THIS.

    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 49 YR Hospitalization