BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3781770 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10012
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    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 AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC FOR FOLLOW-UP. POST-PACED T-WAVE OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260754 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR