BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 4173894 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16714
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 DEVICE DELIVERED INAPPROPRIATE HV THERAPY. PROGRAMMING CHANGES WERE MADE AND PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654040 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3251-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention