BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE VR

    MDR report key: 2984417 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00532
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    August 8, 2012
    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
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF BACKUP VVI RESET MODE WAS CONFIRMED IN THE LABORATORY. THE CAUSE OF THE RESET WAS FOUND TO BE DUE TO A POWER ON RESET. DURING BENCH TESTING, IT WAS FOUND THAT THERE WAS A DAMAGED COMPONENT ON THE HIGH VOLTAGE CIRCUITRY. THE CAUSE OF THE CIRCUIT DAMAGE AND POWER ON RESET COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI, WHEN THE LEAD WAS CONNECTED TO THE NEW DEVICE, THE DEVICE WENT INTO BACK UP VVI MODE AND AN OUTPUT ANOMALY ALERT WAS RECEIVED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88644 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR (B)(4)