INDICATIONS, SAFETY AND WARNINGS

BRIEF STATEMENTS

REVEAL™ INSERTABLE CARDIAC MONITORS

Reveal LINQ™ (LNQ11)

Indications: The Reveal LINQ ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

·         patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

·         patients who experience transient symptoms that may suggest a cardiac arrhythmia.

Contraindications: There are no known contraindications for the insertion of the Reveal LINQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Warnings and precautions

Avoiding effects of electrical interference in the home, work, and other environments: The Reveal LINQ ICM is designed to monitor and store ECG data and to receive radio signals from the programming head and the Patient Assistant. Since the device communicates with the programming head and Patient Assistant by means of radio frequency telemetry, certain types of electromagnetic interference (EMI) may cause temporary telemetry interruptions, trigger inappropriate episode detection, corrupt the data stored in memory, or result in an electrical reset of the device (see Section B.2 of the manual). The device will function normally as soon as the patient moves away from the source of interference. The device should not be affected by the normal operation of electrical equipment such as cell phones, household appliances, electrical machine shop tools, microwave ovens, spark-ignited internal combustion engines, radio frequency transmitting systems, or microwave frequency transmitting systems. Although most interference is filtered out, there are some signals in the environment that have similar characteristics to the signals emitted by the programming head or the Patient Assistant, or which could otherwise interfere with device function. For information to share with Reveal LINQ patients about sources of electromagnetic interference (EMI) in the home, at work, and in other environments that patients may need to avoid, see the Medtronic Reveal LINQ Medical Procedure and EMI Precautions Manual for Health Care Professionals.

Magnetic Resonance Imaging (MRI): Although the Reveal LINQ ICM is considered conditionally safe for use in the MRI environment when used under specified conditions, other implanted devices or the patient’s individual medical condition might have an impact on safety and might require additional examination. Medtronic recommends that cardiologists/radiologists validate any already implanted devices or leads by using the Reveal LINQ MRI Technical Manual. We also recommend referencing the Medtronic MRI Resource Library website located at www.medtronic.com/mri. For detailed information on determining if a Reveal LINQ patient can undergo an MRI scan and for precautions related to the procedure, see the Reveal LINQ MRI Technical Manual. For information about additional medical procedures that are likely to be sources of interference or to be hazardous, see the Medtronic Medical Procedure and EMI Precautions Manual for Health Care Professionals. This manual provides warnings, precautions, and guidance for health care providers who perform medical therapies and diagnostic procedures on patients with cardiac devices.

Potential adverse events: Potential adverse events include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

Patient Assistant (PA96000)

Indications: The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant is used to initiate recording of cardiac event data in the device memory of the ICM.

Contraindications: There are no known contraindications for the use of this device.

Warnings and precautions

Warning: The Patient Assistant is not intended to be used as an alarm system for situations where medical attention is needed. Seek medical attention immediately if you are feeling ill and think you might need to go to the hospital. If there is an emergency, call your local emergency number. If your doctor has provided other instructions, follow them. Waiting to seek medical attention could be dangerous to your health. Caution: To prevent the risk of infection, do not place the Patient Assistant in direct contact with your incision site until it is completely healed. Caution: Do not modify this equipment. Modifications may impair the effectiveness of the Patient Assistant. Caution: Use the Patient Assistant only as directed by your doctor. Do not “play” with your Patient Assistant, including unnecessarily pressing the Record Symptom button, because doing so can cause inappropriate data to be recorded. Caution: Do not take the Patient Assistant into the MRI-controlled room (magnet room). Doing so can damage the Patient Assistant or the MR scanner.

Reveal XT (9529)

Indications:  The Reveal XT Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

·         patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

·         patients who experience transient symptoms that may suggest a cardiac arrhythmia

Contraindications: There are no known contraindications for the implant of the Reveal XT Insertable Cardiac Monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Potential adverse events: Potential adverse events include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

Patient Assistant (9538/9539)

Indications: The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

·         To verify whether the implanted device has detected a suspected arrhythmia or device related event.

·         To initiate recording of cardiac event data in the implanted device memory.

The Patient Assistant is not intended to detect or indicate the presence or absence of medical conditions. Instruct the patient to seek immediate medical attention if he or she is feeling ill, regardless of indications from the Patient Assistant. As directed by the clinician, the patient uses the Patient Assistant during or immediately after a symptomatic event. By pressing a button on the Patient Assistant and holding it in front of his or her implanted device, patients may record the event into the memory of the implanted device. At follow-up visits the implanted device recording is used to check the patient’s cardiac rhythm and help determine if the patient’s symptoms are cardiac related. The patient should be advised to carry or keep their Patient Assistant nearby at all times to avoid the possibility of missing an opportunity to mark a symptomatic episode.

Caution: Do not take the Patient Assistant (handheld activator) into the MRI controlled room (magnet room). Doing so can damage the Patient Assistant or the MR scanner.

REVEAL LINQ™ MOBILE MANAGER SYSTEM (MSW001/MSW002)

Intended Use: The Reveal LINQ™ Mobile Manager app is intended for programming and interrogating the Reveal LINQ™ Insertable Cardiac Monitor.

Contraindications: There are no known contraindications.

Required IT network characteristics and configuration

The use of this system requires your network to have Internet access for the following purposes:

·         Install and update the app from the app store.

·         Communicate with the CareLink™ Network

·         Patient enrollment

The use of this system also requires that Bluetooth® is enabled on your tablet. Failure to provide IT network access results in the following effects:

·         Installation and updates to the app cannot be completed if the tablet is unable to access the app store.

·         Patient enrollment cannot be completed through the app.

·         Comprehensive review of the Reveal LINQ™ ICM data and facilitation of patient enrollment in the CareLink™ Network cannot be completed if the app is unable to access the CareLink™ Network.

·         The system cannot communicate with the implantable device if the tablet is unable to establish a Bluetooth connection with the patient connector.

Follow your organisation's processes and policies to configure your network.

Supported tablets and technical specifications: For the list of supported tablets, and their specifications including network connectivity specifications, go to the following website: www.medtronic.com/24965

Precautions when connecting to your IT network: Connecting the app to an IT network that includes other equipment could result in unforeseen risks to patients, operators, or third parties. Changes to your IT network could also introduce additional risks. Analyse, evaluate and control any risks identified.

Intended information flows: Reveal LINQ™ ICM data and system logs are sent for processing through the system components in the following sequential order: 1. Reveal LINQ™ ICM 2. Patient Connector 3. App installed on the tablet 4. Internet 5. CareLink™ Network In response, a confirmation receipt is sent from the CareLink™ Network via the Internet to the app. PDF report requests are sent from the app via the Internet to the CareLink™ Network. In response, the CareLink™ Network sends the PDF report via the Internet to the app. The CareLink™ Clinic search criteria are sent from the app via the Internet to the CareLink™ Network. In response, the corresponding CareLink™ Clinic's details are sent by the CareLink™ Network via the Internet to the app. All information in transit is protected for security.

Security: Data in the app is protected by application level encryption. The app does not provide data protection for data exported from it to another destination. Data exported from the app should be handled in accordance with your clinic's security policy for data handling and storage. To help protect patient health information and to prevent unauthorised programming of the Reveal LINQ™ ICM, security measures for your tablet should include the following items:

·         Implement a passcode and PIN to protect the tablet.

·         Only use the app and the patient connector on a managed, trusted, and secured network.

·         The app should be used by healthcare professionals only in a hospital or clinical environment. Monitor all user interactions with the tablet.

Patient Connector (24965)

Intended use: The patient connector is a portable electronic device using low frequency inductive telemetry to communicate with Medtronic implantable heart devices. The patient connector uses Bluetooth technology to transmit implantable heart device data to a Medtronic Mobile app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.

Contraindications: There are no known contraindications for the use of this device.

Warnings: These warnings apply in general to using the patient connector settings. For more information related to specific implantable device models, see the reference guides for the implantable device and the software. Battery exposure – Exposing the patient connector to cold temperatures may result in a loss of performance and shortened patient connector service life. Damage due to impact – Do not use the patient connector if it has sustained impact damage. Internal components may be damaged or exposed. Use of damaged equipment may impact user or patient safety. Magnetic Resonance (MR) Unsafe – The patient connector is MR Unsafe. Do not bring the patient connector into Zone 4 (magnet room), as defined by the American College of Radiology. Modification of equipment – Do not modify this equipment. Modifications may reduce system effectiveness and impact user or patient safety. Modifying the patient connector without the approval of Medtronic could void the user’s authority to operate the equipment. Unauthorised use – The patient connector can be used with any compatible mobile device onto which the app is installed. Inappropriate programming could result if untrained persons obtain the patient connector and a REVEAL LINQ patient allows them to use it with the patient’s device. Use of unapproved power supply – Use only the Medtronic-supplied power supply with the patient connector. Use of an unapproved power supply may damage equipment or impact user or patient safety.

Precautions

Radio-frequency (RF) interference – Portable and mobile RF communications equipment can interfere with the operation of the patient connector. Although this system has been approved, there is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the patient connector and mobile device within 2 m (6 feet) of a television, computer monitor or screen, or other wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, “walkie-talkies”, or radio frequency identification (RFID) and security systems. Using your patient connector near these devices could interfere with communication between your implantable heart device and the patient connector.

Security – Maintain adequate physical security of the patient connector to prevent unauthorised use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.

Use of wireless devices – The patient connector incorporates radio-frequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorised by the responsible organisation. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorised by the responsible organisation. However, there is no guarantee that interference will not occur in a particular installation. If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures:

·         Reorient or relocate the patient connector and other devices.

·         Increase the separation between the patient connector and other devices by at least two meters (approximately 6 feet). Other devices include, but are not limited to, cellular phones, computer screens, wireless network devices, and ‘walkie-talkies’.

·         Turn off any interfering equipment.

The Medtronic MyCareLink patient monitor and the Medtronic CareLink network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink patient monitor must be on and in range of the device.  Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

Medtronic MyCareLink™ Patient Monitor (24950), Medtronic CareLink™ Network, and CareLink™ Mobile Application

Intended Use: The Medtronic MyCareLink patient monitor and CareLink network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. The CareLink mobile application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the internet is required and subject to coverage availability. Standard text message rates apply.

Contraindications: There are no known contraindications.

Warnings and Precautions:

·         The MyCareLink patient monitor must only be used for interrogating compatible Medtronic implantable devices.

·         For safe operation of the implanted device, the monitor’s reader should only be used as described in the Patient Manual and as directed by the physician. Patients should always turn the monitor on before positioning the reader over the implanted device. Patients should not use a mobile phone while the reader is positioned over the implanted device.

·         If the monitor does not operate as described in the Patient Manual, the patient should remove the reader from over the implanted device, turn the monitor off and restart the monitor before using the monitor again.

·         As outlined in the Patient Manual, patients should use the monitor as instructed by their physician. Patients should send information only when directed to do so by their physician.

·         The monitor is designed to work only with the implanted device of the patient for whom it was prescribed. It will not work with other patients’ implanted devices and should only be used as authorised by the physician. Unauthorised use by others could affect the functioning of their implanted device or otherwise be harmful to their health.

·         In patients with more than one Medtronic implanted heart device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor.

In addition, the patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient. A Medtronic Programmer can be used to obtain data from each implanted heart device. The physician should contact a Medtronic representative with questions about patients with more than one Medtronic implanted heart device.

See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan device, see the MRI SureScan® technical manual before performing an MRI. For further information contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu .

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Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorisation for use.