BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4031755 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14762
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    May 10, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, INAPPROPRIATE ATP AND HV THERAPY WAS DELIVERED DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE BEING MISDIAGNOSED AS VENTRICULAR TACHYCARDIA. THE DEVICE DIAGNOSED THE ARRHYTHMIA AS A VT DUE TO AT UNDERSENSING OF FINE ATRIAL FIBRILLATION WAVES. PROGRAMMING AND MEDICATION CHANGES WERE MADE TO RESOLVE THE ISSUE. THE PATIENTS CONDITION WAS FINE AND WILL BE FOLLOWED REMOTELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510139 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention