BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4997873 · Received August 12, 2015

    Report

    Report Number
    2938836-2015-28388
    Event Type
    Death
    Date Received
    August 12, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 22, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532054 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120Q/65 3220887

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death 2088TC/52, (B)(4)