BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA ST VR

    MDR report key: 4021789 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14398
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    June 21, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DEVELOPED AN INFECTION. THE DEVICE WAS REMOVED.PATIENTS CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499407 FORTIFY ASSURA ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1359-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention