Inspire System Models 3024, 4063, 4323 English 39
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
The device-related adverse events are described in Table 5.
Table 5. Device-Related Adverse Events
(and the probability of experiencing them in the first 18 months)
At the completion of the 18-month follow-up visits of all study patients, 75% of device-related
events were fully resolved, primarily with either medication, device reprogramming, dental work
to fix a jagged tooth, or with the aid of a lower tooth guard used during sleep to prevent tongue
abrasions, or no intervention. Twenty-five percent (25%) of device-related events were
unresolved at 18 months. Currently unresolved events include reports of discomfort due to
stimulation, tongue abrasion and various stimulation related events including dry mouth,
headaches, intermittent waking, isolated stimulation sensation events, audible buzzing, and
intermittent fatigue. Despite these reported events, patients continued to report high (85%)
compliance with the therapy at 18 months.
Two subjects had their devices removed, which required a surgical procedure. One chose to
have the stimulator removed, and the leads were capped and left in the patient. The other had
the entire system removed as a precaution due to proximity to an infection. Both explants were
successfully completed without damage to the surrounding structures. There were 3 deaths
over the course of the study, all of which were unrelated to Inspire therapy. There were 32
serious adverse events (SAE), 2 of which were related to Inspire therapy.
Event Number of Subjects
with Event
Percent of Subjects
(n=126)
Discomfort due to electrical
stimulation
59 47%
Tongue abrasion 30 24%
Other acute symptoms (i.e.,
headaches, coughing, choking,
dysphasia, and speech-related
events)
23 17%
Mouth dryness 14 11%
Complaints related to temporary
usability or functionality issues
with an implanted device
13 11%
Complaints related to temporary
usability or functionality issues
with an external device
13 10%
Mechanical pain associated with
presence of device
10 8%
Mild infection 1 1%
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