BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA (DDQP+)

    MDR report key: 6204201 · Received December 26, 2016

    Report

    Report Number
    2938836-2016-21967
    Event Type
    Death
    Date Received
    December 26, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 29, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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 SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. 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
    854278 QUADRA ASSURA (DDQP+) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3265-40 3882316

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4)| (B)(4)| (B)(4)