BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 1901312 · Received February 2, 2010

    Report

    Report Number
    1028232-2010-00080
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 20, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER (B)(6) , DISLODGEMENT OF THIS ATRIAL LEAD WAS DISCOVERED AT A ROUTINE F/U. THE LEAD WAS SUCCESSFULLY REPLACED ON (B)(6) 2010.

    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 66 YR Hospitalization