BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3801299 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10954
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 5, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. ALL THERAPY CAPABILITIES WERE DISABLED ON THE DEVICE PER FAMILY REQUEST. THE PATIENT WAS VERY ILL AND LATER EXPIRED DUE TO SEPSIS AND ORGAN FAILURE, UNRELATED TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279540 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention