Indications, Safety & Warnings
Brief Statement: Medtronic CareLink Monitor/Medtronic CareLink Network
Intended Use
The Medtronic CareLink Monitor and the Medtronic 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. 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.
Contraindications
There are no contraindications for the Medtronic CareLink Monitor.
Warnings and Precautions
The Medtronic CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The Medtronic CareLink Monitor is intended for use within the prescribing country.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Brief Statement: 9539 Reveal® XT Patient Assistant
Indications
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.
9539 Reveal® XT Patient Assistant
The Reveal XT 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.
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.
Warnings/Precautions
9529 Reveal XT Insertable Cardiac Monitor
Patients with the Reveal XT 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. MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual.
9539 Reveal XT Patient Assistant
Operation of the Model 9539 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 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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