BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA ICD

    MDR report key: 9526421 · Received December 27, 2019

    Report

    Report Number
    2017865-2019-18531
    Event Type
    Death
    Date Received
    December 27, 2019
    Date of Event
    December 6, 2019
    Report Date
    December 27, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 THE PATIENT DECEASED. 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 WAS UNKNOWN. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-18534. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-18536.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319755 QUADRA ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3367-40C S000027188

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death DURATA STS OPTIM| QUARTET