BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 4170233 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02813
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    March 2, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT SENT A MERLIN.NET REPORT TO A CLINIC WITH A DEVICE THAT WAS POST SENSED T WAVE OVERSENSING. THE PATIENT RECEIVED INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPY. THE OVERSENSING WAS NOTED ON A STORED ELECTROGRAM. REPROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23709 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD1231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR