Inspire System Models 3024, 4063, 4323 English 11
200-079-101 Rev A
3024EN_ch.fm 5/6/14 10:31 pm
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
Contraindications
Contraindications for the use of Inspire UAS therapy include the following:
• Central + mixed apneas > 25% of the total apnea–hypopnea index (AHI)
• Any anatomical finding that would compromise the performance of upper airway
stimulation, such as the presence of complete concentric collapse of the soft palate
• Any condition or procedure that has compromised neurological control of the upper airway
• Patients who are unable or do not have the necessary assistance to operate the sleep
remote
• Patients who are pregnant or plan to become pregnant
• Patients who will require magnetic resonance imaging (MRI)
• Patients with an implantable device that may be susceptible to unintended interaction with
the Inspire system. Consult the device manufacturer to assess the possibility of interaction.
Adverse Effects
Possible adverse effects include, but are not limited to, the following patient related conditions:
• Damage to blood vessels in the vicinity of implant
• Excessive bleeding
• Nerve trauma or damage
• Allergic and/or rejection response to the implanted materials
• Infection
• Local irritation, seroma, hematoma, erosion, or swelling
• Persistent pain, numbness, or inflammation at the implant site
• Discomfort from the stimulation
• Tongue movement restrictions, irritation resulting from tongue abrasions on preexisting
sharp or broken teeth
• Tongue soreness or weakness
• Problems with swallowing or speaking
• Undesirable change in stimulation over time, possibly related to tissue changes around the
electrode(s), shifts in electrode position, loose electrical connections, or lead fractures
• Fibrosis to the extent that it makes it difficult to remove the system without damaging
surrounding structures
•Dry mouth
• Other acute symptoms (i.e., headaches, coughing, choking, dysphasia, and speech
related events)
• Insomnia
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