BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 2629868 · Received June 22, 2012

    Report

    Report Number
    1028232-2012-01631
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 13, 2012
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P9500037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE AND THE RV LEAD WERE EXPLANTED AND REPLACED DUE TO TOTAL LOSS OF SENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD NVZ BIOTRONIK, INC. 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization