BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 11746723 · Received April 29, 2021

    Report

    Report Number
    2017865-2021-16863
    Event Type
    Death
    Date Received
    April 29, 2021
    Date of Event
    March 20, 2021
    Report Date
    July 19, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS COMPLETED. NO DEVICE PROBLEM FOUND.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-16869, 2017865-2021-16873, 2017865-2021-16874. IT WAS REPORTED THE PATIENT HAD PASSED AWAY. NO CAUSE OF DEATH WAS PROVIDED. LAST REMOTE TRANSMISSION SHOWED NO ABNORMALITIES WITH THE SYSTEM. THERE WAS NO ALLEGATION THE SYSTEM HAD ANY ROLE IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641584 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000086950 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR| QUARTET| TENDRIL STS| DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR| QUARTET| TENDRIL STS