BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4153559 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16410
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 29, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, POST PACED T-WAVE OVERSENSING ON VENTRICULAR CHANNEL WAS OBSERVED. PROGRAMMING CHANGES WERE MADE AND DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632278 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR