BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3101181 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01957
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 VIA (B)(4) A PATIENT ALERT FOR AT/AF WAS TRIGGERED. A SINGLE NSLN WAS ALSO NOTED. REVIEW OF THE NSLN SHOWED NO NOISE ON THE LEAD, BUT OVERSENSING OF SIGNALS. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203525 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR