BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3210770 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03455
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 7, 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
    TX
    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 NON SUSTAINED LEAD NOISE EPISODE WAS OBSERVED DUE TO OVERSENSING IN THE ATRIAL CHANNEL. REPROGRAMMING THE DEVICE WAS RECOMMENDED. THE ISSUE WILL BE REVISITED ON THE NEXT FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311257 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 64 YR