Mintek LV, LV-T 1.2%, 1.8%, 6.7%, Total, Total, 12.8%, Total, 17.7%, Procedure, Procedure, Total—All, Categtories, Patients and, Other Medical, Device Related

48 Stratos LV/LV-T Technical Manual

Table 12: OVID and AVAIL Complication-Free

Rate - Stratos LV

	Number	% of	Number of	Complications
Category	of			per patient-
		Patients	Complications
	Patients			year
		Device Related
Pocket	2	1.2%	3	0.02
Infection
Total	2	1.2%	3	0.02
		Procedure
Pneumothorax	1	0.6%	1	0.01
User error	1	0.6%	1	0.01
Hematoma	1	0.6%	1	0.01
Total	3	1.8%	3	0.02
Total Lead,
Device and	21	12.8%	23	0.18
Procedure
Related
		Other Medical
Arrhythmias	1	0.6%	1	0.01
Repeated	3	1.8%	3	0.02
ablation
Worsening	2	1.2%	2	0.02
CHF
Other Medical	3	1.8%	3	0.02
Non-CHF
cardiac	3	1.8%	3	0.02
symptoms
Total	11	6.7%	12	0.09
Total—All	29	17.7%	35	0.27
Patients and
Categtories

Number of Patients = 164 Number of Patient-Years = 127.7