BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 12025604 · Received June 18, 2021

    Report

    Report Number
    2017865-2021-22992
    Event Type
    Death
    Date Received
    June 18, 2021
    Date of Event
    May 14, 2021
    Report Date
    July 28, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22993, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22994, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22995. IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIOGENIC SHOCK WITH ACUTE ON CHRONIC SYSTOLIC HEART FAILURE AND ISCHEMIC CARDIOMYOPATHY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920266 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000075021 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death