Possible adverse effects include, but are not limited to, the following patient related conditions:
- Damage to blood vessels in the vicinity of the implant.
- Excessive bleeding.
- Nerve trauma or damage.
- Allergic and/or rejection response to the implanted materials.
- 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 (ie, headaches, coughing, choking, dysphasia, and speech related events)