BEUDAMED
    FDA Recall Terminated

    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia

    Recall: Z-2733-2011 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-2733-2011
    Event Number
    58686
    Firm
    St Jude Medical CRMD
    FEI Number
    2017865
    Product Code
    MXC
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    March 31, 2011
    Posted
    July 5, 2011
    Terminated
    July 19, 2011
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia

    Reason

    The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM

    Action

    St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774

    Distribution

    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany

    Quantity

    83 units