BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6158635 · Received December 9, 2016

    Report

    Report Number
    2938836-2016-16094
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 30, 2016
    Report Date
    October 31, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED HIGH VENTRICULAR RATE EVENTS OCCURRED DUE TO ATRIAL FIBRILLATION. THE EVENTS WERE MISCLASSIFIED AS VENTRICULAR FIBRILLATION EVENTS AND THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE PHYSICIAN BELIEVES THE EVENTS WERE DUE TO PROGRESSION OF THE PATIENT'S DISEASE PROCESS. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION AND MONITORED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813641 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC P000030799

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention