BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC PLUS VR

    MDR report key: 4092033 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05090
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT HAD POST SENSED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY AND THE OVERSENSING WAS NOTED ON THE STORED ELECTROCARDIOGRAM. TECHNICAL SERVICES DISCUSSED REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22871 EPIC PLUS VR IMPLANTABLE CARDIOVERTER DIFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CRMD V-196

    Patients

    Seq Age Sex Outcome Treatment
    1