BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3903743 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12848
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    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 AFTER RECEIVING INAPPROPRIATE ATP AND HV THERAPY DUE TO ATRIAL TACHYCARDIA WITH VENTRICULAR RESPONSE. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380484 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR