BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP (DDQP+)

    MDR report key: 5041366 · Received August 30, 2015

    Report

    Report Number
    2938836-2015-28903
    Event Type
    Death
    Date Received
    August 30, 2015
    Date of Event
    August 7, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    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. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574048 QUADRA ASSURA MP (DDQP+) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3269-40Q 4153580

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death