BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3903810 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12912
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 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
    TN, 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 PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE THERAPY FOR SUPRAVENTRICULAR TACHYCARDIA WITH RAPID VENTRICULAR RESPONSE. PROGRAMMING CHANGES WERE MADE, AND ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380948 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention