LINQ II INSERTABLE CARDIAC MONITOR
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.
Possible risks associated with the implant of the LINQ II insertable cardiac monitor include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin, and/or sensitivity to the device material. Accessories available for use with LINQ II may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.
The LINQ II insertable cardiac monitor is prescribed by your physician and is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this product, results may vary. For further information, please call Medtronic at +44 (0) 1923 212213 or see the Medtronic website at www.medtronic.co.uk
REVEAL LINQ INSERTABLE CARDIAC MONITOR
The Reveal LINQ™ 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 such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia.
The device has not been tested specifically for pediatric use.
Possible risks associated with the implant of the Reveal LINQ insertable cardiac monitor include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin, and/or sensitivity to the device material.
Treatment with a Reveal LINQ insertable cardiac monitor is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary. For further information, please call Medtronic at +44 (0) 1923 212213 or see the Medtronic website at www.medtronic.co.uk
PATIENT ASSISTANT
The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal insertable cardiac monitor to initiate recording of cardiac event data in the implanted device memory.
Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.
Medtronic MyCareLink Patient Monitor
The Medtronic MyCareLink™ Patient Monitor is a prescription product 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 MyCareLink Patient Monitor transmissions to the CareLink™ network are subject to cellular service availability. The MyCareLink Patient Monitor must be on and in range of the device in order to wirelessly receive data from your implanted device. This product is not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.
The Medtronic CareLink™ service is prescribed by your physician. This service is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this service, results may vary. For further information, please call Medtronic at +44 (0) 1923 212213 or see the Medtronic website at www.medtronic.co.uk
Reveal XT Insertable Cardiac Monitor
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 such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
Possible risks associated with the implant of a Reveal XT insertable cardiac monitor include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin, and/or sensitivity to the device material.
Treatment with a Reveal XT insertable cardiac monitor is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary. For further information, please call Medtronic at +44 (0) 1923 212213 or see the Medtronic website at www.medtronic.co.uk at www.medtronic.com.
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Important Safety Information
Brief Statement: REVEAL LINQ™ LNQ11 Insertable Cardiac Monitor and Patient Assistant 9538
Indications
REVEAL LINQ™ LNQ11 Insertable Cardiac Monitor
The Reveal LINQ 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 such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia.
9538 Reveal® Patient Assistant
The Reveal Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Warnings/Precautions
REVEAL LINQ™ LNQ11 Insertable Cardiac Monitor
Patients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual.
9538 Reveal Patient Assistant
Operation of the Model 9538 Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.
Potential Complications
Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at +44 (0) 1923 212213 and/or consult Medtronic’s website at www.medtronic.co.uk
Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink® Network and CareLink™ Mobile Application
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.
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.
Contraindications
There are no known contraindications.
Warnings and Precautions
The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at +44 (0) 1923 212213 and/or consult Medtronic’s website at www.medtronic.co.uk
Additional Device Information
9529 Reveal® XT Insertable Cardiac Monitor
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 such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia
Possible risks associated with the implant of a Reveal XT Insertable Cardiac Monitor include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin and/or sensitivity to the device material.
Treatment with a Reveal XT Insertable Cardiac Monitor is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary. For further information, please call the Medtronic at +44 (0) 1923 212213 or see the Medtronic website at www.medtronic.co.uk