BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 7144947 · Received December 22, 2017

    Report

    Report Number
    2938836-2017-35404
    Event Type
    Death
    Date Received
    December 22, 2017
    Date of Event
    October 19, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CONGESTIVE HEART FAILURE. 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 IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923542 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q A000027992

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death