BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 45

    MDR report key: 2860131 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-02982
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    THE ATRIAL LEAD HAS INTERMITTENT CAPTURE AT 7.0 V AT 1 MS THE DAY AFTER IMPLANT. A LEAD MICRODISLODGEMENT IS SUSPECTED AND AN X-RAY WILL BE DONE TO CONFIRM.

    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 32 YR Hospitalization