BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3854652 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11613
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 A MERLIN.NET TRANSMISSION SHOWED EPISODES OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING. THE OVERSENSING WAS OBSERVED ON THE EGMS. THE PATIENT WAS ASYMPTOMATIC. PROGRAMMING CHANGES WERE RECOMMENDED AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332154 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR