BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 7012168 · Received November 8, 2017

    Report

    Report Number
    2938836-2017-33760
    Event Type
    Death
    Date Received
    November 8, 2017
    Date of Event
    September 26, 2017
    Report Date
    March 1, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    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. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION STATES THAT PATIENT WAS HOSPITALIZED FOR NAUSEA AND EPIGASTRIC PAIN ON (B)(6) 2017. THE NEXT DAY, THE PATIENT HAD AN EPIGASTRIC SURGERY FOR HIATAL HERNIA. ON (B)(6) 2017, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL¿S PALLIATIVE CARE, WHERE THE PATIENT SUFFERED OF HALLUCINATIONS AND CONFUSION. MORPHINE AND DILAUDID WAS GIVEN TO THE PATIENT FOR PAIN RELIEF. THE NEXT DAY, THE PATIENT EXPIRED DUE TO CARDIAC INSUFFICIENCY. THERE IS NO ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790811 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC A000017467

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death