BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6946752 · Received October 12, 2017

    Report

    Report Number
    2938836-2017-32747
    Event Type
    Death
    Date Received
    October 12, 2017
    Date of Event
    September 25, 2017
    Report Date
    October 12, 2017
    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

    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 IS UNKNOWN. THE PHYSICIAN SUSPECTS THAT THE PATIENT MIGHT HAVE HAD A PULMONARY EMBOLISM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725061 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3369-40Q A000042718

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death