BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 6118279 · Received November 21, 2016

    Report

    Report Number
    2938836-2016-14504
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    September 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF SHORTNESS OF BREATH AND NOT FEELING WELL. PATIENT'S RECENT DEVICE WOUND SHOWS LIKELY CELLULITIS. IV ANTIBIOTICS WERE STARTED AND PATENT ADMITTED TO THE HOSPITAL. PATENT DECLINED AND TACHY THERAPIES WERE DISCONTINUED BY THE PHYSICIAN. IT WAS REPORTED THAT THE PRIMARY CAUSE OF DEATH WAS CARDIAC-PUMP FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767862 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120/65 2775958

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death 1258T/86, (B)(4)| 2088TC/46, (B)(4)| CD3357-40C, 7207931