BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 4081395 · Received January 14, 2014

    Report

    Report Number
    2938836-2014-06145
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    June 14, 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 WITH A DEVICE THAT WAS POST PACED T WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT DID NOT RECEIVED INAPPROPRIATE THERAPY. PROGRAMMING CHANGES WERE MADE. WHEN POST PACED T WAVE OVERSENSING OCCURED AGAIN ON THE VENTRICULAR CHANNEL, FURTHER PROGRAMMING CHANGES WERE MADE. THE DEVICE REMAINS IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34965 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD CD2311-36

    Patients

    Seq Age Sex Outcome Treatment
    1