BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3943891 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13518
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 5, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP. REAL TIME EGM'S REVEALED POST PACED T WAVE OVERSENSING ON VENTRICULAR LEAD. PROGRAMMING CHANGES WERE MADE DURING DEVICE CHECK AND RESOLVED THE OVERSENSING ISSUE. NO OTHER OBSERVATIONS WERE NOTED. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421793 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR