BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    MDR report key: 3210625 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03441
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED TO THE ER AFTER RECEIVING AN INAPPROPRIATE SHOCK FOR AF WITH RVR. DEVICE WAS REPROGRAMMED. PATIENT TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310339 UNIFY QUADRA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3249-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention