BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3914482 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13113
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO POSSIBLE SINUS TACHYCARDIA WITH DYSRHYTHMIA AND RAPID VENTRICULAR RESPONSE. THE EPISODE WAS SEEN VIA REMOTE TRANSMISSION. PROGRAMMING CHANGES WERE RECOMMENDED. HOWEVER, THE PATIENTS MEDICATION WAS ADJUSTED. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389543 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR