BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 3220055 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04492
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 30, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EXTENDED CHARGE TIME ANOMALY WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE IDENTIFIED INTERNAL DAMAGE TO THE HIGH VOLTAGE CAPACITOR. THIS WOULD ACCOUNT FOR THE HIGH VOLTAGE CHARGE TIMES.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING CHARGE TIME LIMIT REACHED NOTIFIER. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319833 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention