BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA CRT-D QUAD RF HV

    MDR report key: 6173553 · Received December 14, 2016

    Report

    Report Number
    2938836-2016-15922
    Event Type
    Death
    Date Received
    December 14, 2016
    Date of Event
    October 30, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH USING AUTOMATED TESTING EQUIPMENT, AND NO ANOMALIES WERE 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 SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS CORONARY OCCLUSION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824854 QUADRA ASSURA CRT-D QUAD RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3365-40Q A000008036

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death (B)(4)| (B)(4)| (B)(4)