BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 3872919 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11794
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY. THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY. PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349493 FORTIFY ASSURA VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention