BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3791060 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10419
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 24, 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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REMOTE TRANSMISSION THAT NON-SUSTAINED LEAD NOISE DUE TO INTERMITTENT OVERSENSING ON THE VENTRICULAR SENSE AMP CHANNEL WAS OBSERVED. LOW LEVEL SIGNAL WAS NOTED ON THE SENSE AMP CHANNEL. THE PHYSICIAN ELECTED NOT TO MAKE ANY PROGRAMMING CHANGES. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269131 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR