BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3210567 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03459
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 16, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE DEVICE WAS POST-PACED T-WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311520 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR