BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR

    MDR report key: 2984508 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00545
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 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
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF BVVI WAS CONFIRMED IN THE LABORATORY. ANALYSIS OF THE DEVICE DETERMINED THAT A BAD MEMORY READ WAS THE CAUSE OF THE RESET. ALTHOUGH IT COULD NOT BE CONCLUSIVELY DETERMINED, IT IS BELIEVED THAT THE ROOT CAUSE OF THE FAILURE IS DUE TO AN ANOMALOUS COMPONENT WITHIN THE HYBRID CIRCUITRY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A PATIENT NOTIFIER. UPON INTERROGATION THE DEVICE WAS FOUND TO BE IN BACK UP VVI MODE. AFTER UNSUCCESSFUL ATTEMPTS TO RESTORE THE DEVICE OUT OF BACK UP MODE, THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88397 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR