BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6057278 · Received October 26, 2016

    Report

    Report Number
    2938836-2016-13045
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    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 ON DEATH CERTIFICATE NOTES CONGESTIVE HEART FAILURE, RHEUMATOID ARTHRITIS, HYPERTENSIVE HEART DISEASE AND INTERSTITIAL LUNG DISEASE. THE MANNER OF DEATH WAS NATURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707627 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q 4525754

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death (B)(4)| (B)(4)| (B)(4)