BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 3920900 · Received July 8, 2014

    Report

    Report Number
    2938836-2014-13317
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    April 14, 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
    MN, 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 DEVICE DELIVERED INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPY. AN ALERT FOR AUTOCAPTURE IN HIGH OUTPUT MODE WAS ALSO NOTED. MORPHOLOGY TEMPLATE UPDATE AND PROGRAMMING CHANGES WERE RECOMMENDED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398348 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR