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Indications for Use

The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients. 

Contraindications

  • The remedē System is contraindicated for the following:
    • Patients with an active infection

Warnings

  • Carefully read all warnings, precautions, and instructions before use. 
  • Activity after the procedure. Do not raise your arm above the shoulder on the side the device is placed for 1-3 months. Follow all other advice from your doctor after the device is placed. Failing to follow this advice can cause the leads to get pulled out of place and you might need a second procedure. 
  • Electric Shock -When operating under AC power, the remedē System Programmer must be connected to a grounded power source to avoid risk of electric shock.
  • Observing the implant site after the procedure. If you see redness or swelling at the site of the device, call your doctor without delay. Failing to call your doctor could result in a severe infection and the device may need to be removed. 
  • Carry your ID card. You should carry the remedē System ID card with you at all times. Because the device is placed in the chest similar to heart devices, it could be mistaken for a heart device by doctors. This could delay medical care in an emergency. 
  • Diathermy (the production of heat in the body using electric current which may be used to treat muscle spasms, injuries and bursitis). Do not allow a healthcare provider to use any kind of diathermy on your body. Energy from diathermy can be sent through your device or leads causing tissue damage, which may result in severe injury or death. Diathermy also can damage your device or leads. 
  • Other stimulation devices. Prior to the procedure, be certain your doctor knows if you have another stimulation device. Following the remedē System implantation, contact your doctor if you have other stimulation devices implanted or if you suspect an interaction between the devices such as an ICD shock or changes in your heart rhythm. The remedē System may be used if you have another stimulation device such as a heart pacemaker or defibrillator; special testing will be needed to ensure the devices are not interacting. Devices that interact with each other could result in these devices working incorrectly. For example, electrical pulses from the remedē System may interact with how your cardiac device sees electrical signals from your heart and could result in inappropriate response. Some inappropriate responses may include an unnecessary ICD shock or lack of electrical impulses to make the heart beat. If surgical revisions are made to either the remedē System or the other concomitant implanted device in the future, or if you are implanted with a new stimulation device, special testing will be needed to ensure there are no interactions. 
  • Pacemakers. The remedē System should be used with caution if your heart does not beat without a pacemaker. 
  • Environmental concerns. Electronic equipment such as that designed to prevent theft and airport metal detectors may affect the remedē System. Alert security personnel about the System and request a manual search if possible. If walking through a surveillance system, do not remain near this system longer than needed. 
  • Radiofrequency. Common radiofrequency sources (such as found in identification badges and anti-theft tags) have the potential of affecting normal remedē System operation. A distance of at least 40 centimeters should be kept between the implanted device and any radiofrequency source. 
  • Electrical and magnetic concerns. Electrical and magnetic equipment have the possibility of interacting with the remedē System. Stay away from high powered electromagnetic fields such as arc welding units, induction furnaces, induction stoves, resistance welders, radio or microwave transmitters and linear power amplifiers. Avoid equipment using magnetic fields such as stereo speakers, bingo wands, magnetic badges and magnetic therapy products. 
  • Injury. Avoid activities likely to cause a blow to the skin over the device. This could damage the device or skin over the device. 
  • Pregnancy. The safety and effectiveness of the remedē System has not been tested during pregnancy. 
  • Injury of the phrenic nerve. The remedē System may not work in patients with a prior injury to the phrenic nerve. 
  • Medical procedures. Certain medical procedures and equipment can interact with the remedē System causing changes to the remedē System or interference with the medical equipment. You should tell your physician about your remedē System prior to the use of any of the following: Magnetic resonance imaging (MRI), electrocautery, radiofrequency ablation, radiation, CT scan (computed tomography), therapeutic ultrasound, external defibrillation, patient monitoring equipment or transcutaneous electrical stimulation (TENS). 
  • Scuba diving or hyperbaric chambers. Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) can damage your stimulator or leads. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. 
  • Cellular phones. The remedē System contains a filter to prevent most phones from interacting with the device function. To further decrease the risk of this interaction you should observe these cautions: 
    • Do not place phones in the chest area (e.g. in shirt pockets) on the same side as the device. 
    • Maintain at least 10 inches between the device and the phone, even if the phone is not on. 
    • Hold the phone to the ear farthest from the device. 

It is possible that phones placed close to the remedē System while it is active could result in stronger stimulation than programmed. The phone also could prevent the system from saving data about your breathing.

Precautions

It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device. Use remedē System therapy with caution in pacemaker-dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing. The safety and effectiveness of the remedē System during pregnancy has not been established. See the Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. 

Adverse Effects

Possible adverse events which may be associated with the implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke. 

CAUTION: Rx only. Prior to use, please see the complete “System Implant and Clinician Use Manual” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

For additional information, please download the remedē System Patient Manual here.