BEUDAMED
    FDA Recall Terminated

    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

    Recall: Z-2784-2015 · Initiated August 18, 2015

    Recall

    Recall Number
    Z-2784-2015
    Event Number
    71995
    Firm
    St Jude Medical Cardiac Rhythm Management Division
    FEI Number
    2017865
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    August 18, 2015
    Posted
    September 28, 2015
    Terminated
    May 19, 2016
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.

    Reason

    Some devices exhibit backup VVI operation due to a backup reset.

    Action

    The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015. The firm's notification letter identifies clinical implications. Clinical Implications In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing. This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation. The firm's notification also idenfities recommendations and mitigations. Recommendations and Mitigations Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality. If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.

    Distribution

    Worldwide Distribution-US (nationwide) and foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Saudi Arabia, Hungary, Switzerland.

    Quantity

    259,214 transmitters (U.S. distribution) 23,604 (foreign distribution)