BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3854588 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11574
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT FOR NOISE DUE TO T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. PATIENT WILL BE MONITORED VIA MERLIN.NET. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332340 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1