BEUDAMED
    FDA Adverse Event Death Summary report: N

    SETROX S 45

    MDR report key: 2070282 · Received April 18, 2011

    Report

    Report Number
    1028232-2011-00860
    Event Type
    Death
    Date Received
    April 18, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 6, 2011
    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

    THIS LEAD WAS INSERTED INTO THE PT, BUT PRIOR TO POCKET CLOSURE, THIS PT EXPIRED DUE TO RESPIRATORY ARREST. "THERE WAS NO POTENTIAL LEAD ISSUE THAT LED TO THE PT'S DEATH."

    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 63 YR Death