BEUDAMED
    FDA Enforcement Class II Terminated

    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

    Recall: Z-0033-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0033-2018
    Event ID
    78093
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2017
    Initiation Date
    August 28, 2017
    Classification Date
    October 19, 2017
    Termination Date
    July 8, 2020
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

    Reason

    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

    Code Info

    Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

    Distribution

    Worldwide Distribution

    Quantity

    495,011 units (391,093 in US)