BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 14754244 · Received June 21, 2022

    Report

    Report Number
    2017865-2022-13021
    Event Type
    Death
    Date Received
    June 21, 2022
    Report Date
    July 21, 2022
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H6 CODES HEALTH EFFECT - CLINICAL CODE WAS VENTRICULAR FIBRILLATION SHOULD BE ARRHYTHMIA.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR THE REPORTED EVENT OF PATIENT DEATH DUE TO INADEQUATE HIGH VOLTAGE OUTPUT. AS RECEIVED, THE DEVICE WAS ABOVE ELECTIVE REPLACEMENT INDICATOR. VISUAL EXAMINATION FOUND NO ANOMALIES BESIDES BODY FLUID STAINS IN THE HEADER. THE DEVICE IMAGE WAS ANALYZED AND FOUND NO ANOMALIES AND THE DEVICE PASSED ALL TESTS IN THE UNITY TEST SYSTEM PRODUCT ANALYSIS. THE REPORTED EVENT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-13024. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-13023. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-13022. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO VENTRICULAR FIBRILLATION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DELIVERED SHOCKS BUT WAS UNABLE TO CONVERT RHYTHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158816 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000048177 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Death