BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4153502 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16385
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 17, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN TRANSMISSION REVEALED INAPPROPRIATE HIGH VOLTAGE THERAPY WAS DELIVERED DURING A SUPRAVENTRICULAR TACHYCARDIA EPISODE DUE TO BEING CLASSIFIED AS A VENTRICULAR TACHYCARDIA. PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT HAS NOT BEEN SEEN FOR A FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630987 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR