BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3220369 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04579
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING INAPPROPRIATE ATP AND HV THERAPY. DUE TO PROGRAMMING THE DEVICE DIAGNOSED ATRIAL FIBRILLATION AS VENTRICULAR FIBRILLATION. PROGRAMMING CHANGES WERE MADE AND DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320537 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 85 YR Required Intervention