Programming Manual

9. RISKS AND SIDE EFFECTS

Please discuss the risks and benefits with your doctor to determine if the device is right for you. Risks

of neurostimulation therapy can include surgical risks, possible side effects, or device complications.

Your doctor can provide more information about these and other potential risks. Please follow your

doctor’s instructions after surgery to minimize surgical risk.

Similar to other oral procedures, most patients will experience some or all of the following effects

post-surgery and most effects resolve within 60 days:

• Sensory and/or motor dysfunction, including numbness, other sensations, and/or facial paresis

(slight or incomplete paralysis)

• Post-operative pain, swelling and/or tenderness at the surgery site

Other risks of surgery may include:

• Seroma/Hematoma (a collection of serum/blood in the body)

• Abcess

• Bruising

• Permanent numbness and other sensations

• Dry eye and tearing

• Trismus (lockjaw)

• Itching

• Pain in the area of the implant

• Infection

• Bleeding

• Facial asymmetry

• Allergic response to implanted materials

• Headache

• Penetration of the sinus wall

• Increased severity/frequency of cluster headaches

• Post-operative nausea or emesis (vomiting)

• Nose bleed

• Ear or nasal fullness/rhinorrhea (nasal discharge)

• Taste alteration

Possible side effects of SPG stimulation include:

• Discomfort or pain during stimulation associated with paresthesia (a sensation of tingling,

pricking or numbness in the face)

• Runny nose

• Dry eye and tearing

• Conjunctivitis

• Headache

Device complications may include:

• Microstimulator migration or misplacement potentially leading to explant and/or re-implant

• Inability of the Remote Controller to connect with the Microstimulator

• Device malfunction

• Skin and/or bone erosion around the Microstimulator implant site