Table 4.

Device-related adverse events.

Adverse Event Type1	% Subjects (#)	# Events
All	17.9% (47)	56
Significant and persistent skin irritation (including redness, itchiness, and/or swelling)	5.3% (14)	15
Sore/Lesion	3.8% (10)	11
Significant discomfort	2.3% (6)	7
Electrical burns	2.3% (6)	6
Other: minor skin irritation (including itchiness and/or redness)	2.3% (6)	6
Other: electric shock sensation while using device	1.1% (3)	3
Other: worsening of tremor	0.8% (2)	2
Other isolated events2	2.0% (5)	6

¹ Rated by investigator to be possibly, probably or definitely device-related.

² Each of the following occurred in only one patient: fall, anxiety, intermittent soreness in treated wrist, weakness or lack of coordination in treated hand, persistent pain from stimulation.