BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 3090192 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01171
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 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
    MI
    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 FOLLOW UP, FAR P-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE INAPPROPRIATE THERAPY. REPROGRAMMING TO DECREASE VENTRICULAR SENSITIVITY AND INDUCTION TEST WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192058 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR