BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 3220365 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04494
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 8, 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
    VA
    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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE THERAPY. THE OVERSENSING WAS NOTED ON A STORED EGM. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320954 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR