BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6040351 · Received October 19, 2016

    Report

    Report Number
    2938836-2016-12884
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    March 19, 2016
    Report Date
    September 24, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. 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
    690427 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q 4296535

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 1458Q/86, (B)(4)| 7122Q/58, (B)(4)