BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA DR CRT-D

    MDR report key: 3943847 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13355
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. AN ALERT WAS DELIVERED INDICATING THAT THE DEVICE WAS POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. PROGRAMMING CHANGES WERE MADE IN CLINIC. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421759 QUADRA ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR