BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF-4 CONNECTOR

    MDR report key: 4153541 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16502
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 19, 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
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DELIVERED INAPPROPRIATE ATP THERAPY FOR AN SVT EPISODE. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631469 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 37 YR