BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP

    MDR report key: 6090164 · Received November 9, 2016

    Report

    Report Number
    2938836-2016-13989
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. ACCORDING TO THE PHYSICIAN THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE PERFORMANCE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741135 UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3251-40Q 3607104

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RA, LV AND RV LEADS, UNK SERIAL#