Table 3:

Adverse Events for CHD vs. Non-CHD Patients. Pedimacs Patients, September 19, 2012 to June 30, 2017

	Pedimacs CHD					Pedimacs Non-CHD
Event	Perioda	Events	Patient Count	Patient Percent	Rateb	Events	Patient Count	Patient Percent	Rateb	Rate Ratioc	p-valued
Arterial Non-CNS Thromboembolism	Early					3	3	1%	0.5
Bleeding	Early	33	24	22%	17.9	131	89	26%	19.9	0.9	0.6
	Late	5	4	4%	3.2	12	10	3%	1.4	2.3	0.1
Cardiac Arrhythmia	Early	11	8	7%	6	30	24	7%	4.6	1.3	0.4
	Late					2	2	1%	0.2
Infection	Early	33	23	21%	17.9	93	70	20%	14.1	1.3	0.2
	Late	9	6	6%	5.8	38	26	8%	4.5	1.3	0.5
Neurological Dysfunction	Early	33	25	23%	17.9	87	71	21%	13.2	1.4	0.1
	Late	4	4	4%	2.6	20	12	4%	2.3	1.1	0.9
Other SAE	Early	33	22	20%	17.9	113	68	20%	17.2	1	0.8
	Late	6	5	5%	3.8	19	14	4%	2.2	1.7	0.2
Pericardial Drainage	Early	5	5	5%	2.7	18	16	5%	2.7	1	1.0
Psychiatric Episode	Early	3	3	3%	1.6	21	20	6%	3.2	0.5	0.3
	Late	1	1	1%	0.6	2	2	1%	0.2	2.7	0.4
Renal Dysfunction	Early	12	11	10%	6.5	23	23	7%	3.5	1.9	0.08
	Late	1	1	1%	0.6	2	1	0%	0.2	2.7	0.4
Respiratory Failure	Early	35	23	21%	19	41	34	10%	6.2	3	<.001
	Late	2	2	2%	1.3	3	3	1%	0.4	3.6	0.1
Venous Thromboembolism	Early					6	6	2%	0.9
Wound Dehiscence	Early	1	1	1%	0.5	2	2	1%	0.3	1.8	0.6
	Late					1	1	0%	0.1

^aEarly = within three months of device implant, Late = more than three months after device implant

^bRates are reported per 100 patient months

^cRate Ratio is comparing CHD rates to non-CHD rates for the given time period

^dp-value is comparing CHD rates to non-CHD rates for the given time period