BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 2212894 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01521
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 28, 2011
    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
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED COMPLAINING OF SHORTNESS OF BREATH AND LEG SWELLING. THE DEVICE WAS INTERROGATED, REVEALING LOSS OF SENSING AND PACING OF THIS ATRIAL LEAD. THIS LEAD WAS EXPLANTED AND REPLACED WITH A SELOX JT 45. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 45 PACING LEAD NVZ BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization