BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP¿

    MDR report key: 15757253 · Received November 8, 2022

    Report

    Report Number
    2017865-2022-44765
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 20, 2022
    Report Date
    January 24, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF BACKUP OPERATION COULD NOT BE CONFIRMED BASED ON THE AVAILABLE DEVICE DATA. UPON RECEIPT, THE DEVICE WAS INTERROGATED ON A PROGRAMMER AND NORMAL COMMUNICATION WAS ESTABLISHED. TELEMETRY, IMPEDANCE, SENSING, PACING AND HIGH VOLTAGE (HV) OUTPUT FUNCTIONS OF THE DEVICE WERE TESTED AND FOUND TO BE NORMAL. THE BACKUP OPERATION COULD NOT BE REPRODUCED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT¿S DEVICE ENTERED VVI BACKUP MODE ON THREE SEPARATE OCCASIONS DUE TO DATA CORRUPTION. PATIENT HAD LIGHT HEADED, DIZZY AND SHORT OF BREATH UPON LOSING ATRIOVENTRICULAR (AV) SYNCHRONY WHEN THE DEVICE WOULD GO INTO VVI BACKUP MODE. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WENT HOME WITHOUT ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2442695 QUADRA ASSURA MP¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000093060 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention DURATA| QUARTET| TENDRIL