BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 4153476 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16392
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE INDICATED THE DEVICE ENTERED BVVI MODE ON (B)(6) 2014. THE RESET WAS REPRODUCED DURING TEMPERATURE CHAMBER TESTING. THE ROOT CAUSE OF THE RESETS WAS AN ANOMALOUS COMPONENT ON THE HYBRID.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    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 ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER RECEIVING A PATIENT NOTIFIER FOR BACK-UP VVI. A SUCCESSFUL DEVICE DOWNLOAD WAS PERFORMED. UPON REINTERROGATION, THE DEVICE WENT INTO BACK-UP VVI MODE AGAIN. A SECOND DEVICE DOWNLOAD WAS PERFORMED AND DEVICE WAS RESTORED TO NORMAL OPERATION. THE PATIENT WILL BE MONITORED REMOTELY.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WENT INTO AN UNRECOVERABLE BACK-UP MODE AND WAS EXPLANTED AND REPLACED. THERE WERE NO COMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630457 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention