Summary of post-operative adverse events
Post-titration | Final visit | |||
Events n | Patients % | Events n | Patients % | |
Tongue weakness | 2 | <1 | 0 | |
Swallowing or speech related | 3 | <1 | 0 | |
Discomfort (incision/scar) | 5 | 1 | 5 | 2 |
Discomfort (device) | 7 | 2 | 3 | 1 |
Infection | 0 | 0 | ||
Post-operative – other# | 8 | 2 | 3 | 1 |
Stimulation-related discomfort | 26 | 8 | 15 | 6 |
Tongue abrasion | 7 | 2 | 7 | 3 |
Insomnia/arousal | 6 | 2 | 9 | 3 |
Revision interventions (including explant) | 0 | 1 | <1 | |
Other discomfort | 5 | 1 | 2 | <1 |
Activation – other | 18 | 5 | 16 | 6 |
Total | 87 | 23 | 61 | 23 |
72 patients reported adverse events at the post-titration visit and 50 at the final visit (not mutually exclusive). Some patients reported multiple adverse events. Percentage of patients was calculated based on the number of patients at each visit who completed the visit form, which contains adverse event information. #: includes shortness of breath, seroma, numbness of the throat and hoarseness during the day and a mild tongue-base and epiglottic obstruction.