BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2833054 · Received November 5, 2012

    Report

    Report Number
    1028232-2012-02755
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 25, 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 PHYSICIAN REPOSITIONED THIS RV LEAD DUE TO DIAPHRAGMATIC STIMULATION AND INTERMITTENT CAPTURE ON (B)(6) 2012. THIS LEAD WAS SUCCESSFULLY REPOSITIONED AND REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    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 89 YR Hospitalization