BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP

    MDR report key: 5935990 · Received September 8, 2016

    Report

    Report Number
    2938836-2016-10910
    Event Type
    Death
    Date Received
    September 8, 2016
    Report Date
    August 17, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PHYSICIAN DOESN'T BELIEVE THAT THE DEATH WAS RELATED TO THE DEVICE. THE PATIENT'S RELATIVES ARE CLAIMING DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587014 QUADRA ASSURA MP NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death