BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS VR

    MDR report key: 3880096 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02280
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    February 20, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT WAS POST SENSED TO WAVE OVERSENSING. THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND THE OVERSENSING WAS NOTED ON A STORED ELECTROGRAM. REPROGRAMMING CHANGES WERE RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24866 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD V-196

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR