BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR

    MDR report key: 4030622 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14662
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE ATP AND HV THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA. THE DEVICE FUNCTIONED AS PROGRAMMED. A CHANGE TO THE PATIENT'S MEDICATION IS PLANNED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510062 FORTIFY ASSURA VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR