Risks & Benefits

Risks or side effects

There is a risk of:

• Diaphragm penetration during the procedure, which could cause a condition known as capnothorax
• Infection and/or inflamed tissue at the electrode implantation sites bleeding at the electrode implantation sites
• Nerve, tissue, or organ damage as a result of the procedure
• Electrode wires breaking off in your body, leading to reduced or intermittent diaphragm pacing or failure of the pacing system
• Cardiac arrhythmia being caused by the placement of the electrodes in the chest cavity
• Skin irritation or hypersensitivity from the electrical stimulation, from the tape used with the electrodes or from the skin bandage that holds the electrode connections
• Your body not being compatible with the materials used in the electrodes and their wires
• Choking during eating and of sleep apnea is a Passy-Muir valve is not used during the training period
• Discomfort during the conditioning period – be sure to tell your physician if you notice pain, discomfort or shortness of breath
• Not having a sufficient muscle reaction when using the stimulator and the product may not work for you

Additional considerations

• At this time, there is insufficient clinical data to determine safety in implanting this device in patients with cardiac pacemakers; therefore, you should not be implanted with this device if you have a cardiac pacemaker or other implanted electrical device.
• This product should not be used by patients with suspected or real heart problems, or epilepsy.
• The safety of this device in use during pregnancy is unknown.
• The long-term effects of electrical stimulation of the diaphragm are unknown.

Risks during electrode placement

There is a risk that during electrode placement, the electrodes may go all the way through the diaphragm muscle, which could cause air to gather in your chest and cause a capnothorax. If this occurs, air on your chest may cause both discomfort and hinder your ability to breathe.

Risk of lung collapse

In a worst-case situation, one or both of your lungs could collapse. If a lung does collapse, it will be reinflated immediately, using a tube that is placed in your chest. There may be some discomfort and/or bruising at the site where the lead wires go through the skin. This is temporary and should go away in a few days.

Risks of system malfunction

It is possible that stimulation from the diaphragm pacing system could stop, either due to electrode breakage, cable disconnection, or stimulator failure. If one of these happens, breathing will stop. Without prompt attention, this could result in permanent disability or death. This risk is reduced by using back-up electrodes and sounding an alarm whenever the stimulator detects improper operating conditions.

Risk of aspiration

There is a risk of aspiration when using this device. While becoming used to the stimulation and timing, it is recommended that a one-way (Passy-Muir) valve on your tracheostomy is used while eating or drinking when on the pacing device. It is also recommended to use the one-way valve while sleeping to avoid upper airway obstructions. The Passy-Muir speaking valve looks like a plug with holes in it. The valve fits directly onto the end of your tracheostomy tube. It opens during inspiration to let air into your lungs and closes during exhalation to allow air to pass over your vocal cords and out through your nose and/or mouth. The valve allows for more normal respiration, improves swallowing, and may reduce your risk of aspiration.

Increased spasms during adjustment

You may experience increased spasms with the stimulation while your body becomes used to the stimulation. This typically subsides within a few days of use.

Source: Synapse Biomedical Inc.