Table 5. Procedure complications and device-related adverse events (Non-serious).
| Number of patients reported | % of patients reported (N = 98) | Number of Events Reported | |
|---|---|---|---|
| Pain during stimulation | 15 | 15.3% | 25 |
| Lacrimation (*) | 8 | 8.2% | 8 |
| Complication of device insertion | 5 | 5.1% | 5 |
| Implant misplacement | 5 | 5.1% | 5 |
| Implantation site pain | 4 | 4.1% | 4 |
| Re-implantation | 3 | 3.1% | 3 |
| Implantation site inflammation | 3 | 3.1% | 3 |
| Redness of the face (*) | 3 | 3.1% | 3 |
| Device accidentally removed by patient | 2 | 2.0% | 2 |
| Salivation (*) | 2 | 2.0% | 2 |
| Device malfunction | 1 | 1.0% | 1 |
| Paresthesia | 1 | 1.0% | 1 |
| Implantation site bleeding upon removal | 1 | 1.0% | 1 |
| Wound dehiscence | 1 | 1.0% | 1 |
(*) Expected surrogates of SPG activation, typically not be reported as adverse reactions.