Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration

Table 1 Studies included

Sample	Follow-up1	Response	Adverse Events			Ref.
			Infection	Explant	Reoperation
61	13		0	1	2	[60]
16			0	0	3	[61]
85	24		0	3	13	[45]
39	12		2	2	2	[62]
60	47	17	2	9	15	[18]
101	60	26	2	20	20	[14]
50	55.5		2	6	11	[63]
42			0	2	5	[64]
23	114		2	3	5	[65]
101	62		1	10	39	[66]
37	17	27	0	0	3	[50]
41	51		0	0	6	[67]
34	24	83	1	2	4	[19]
37	6		3	5	5	[68]
58	74	37	0	6	15	[49]
12	117		0	3	14	[69]
29	34		0	0	0	[70]
7	32		1	1	2	[71]
53	12		0	0	0	[72]
10			0	0	1	[73]
29	35		2	2	8	[74]
37	13		2	4	10	[75]
14	6		0	0	0	[76]
87	48.5		4	12	36	[77]
40			3	3	7	[78]
15	6	10	0	0	0	[47]
85	12	31	0	1	1	[54]
145	12	137	5	6	15	[6]
29			0	1	1	[79]
27	10.7		3	1	4	[80]
9	12		0	0	1	[81]
120	60	90	12	30	72	[8]
57	63		2	6	12	[82]
8			0	0	1	[83]
18	17		2	3	4	[84]
50	74		4	11	24	[85]
11	14	6	0	1	1	[51]
55	37		1	1	11	[16]
23	38		0	0	4	[15]
32	33		3	7	10	[17]
53	12		0	0	0	[7]
50	12		2	4	10	[86]
10	29.5	10	2	8	8	[53]
33	27	0		5	11	[87]
16	15.5		0	0	0	[88]

¹Follow up in months.

Table 2 Reported problems based on classification of adverse effects

Reported problem	Injury (n = 228)	Malfunction (n = 424)	P value
Battery depletion	9	6	0.057
Generator displacement	11	5	0.007
Pocket erosion	9	0	< 0.001
Infection	21	0	< 0.001
Pain	41	102	0.091
Lack of benefit	70	243	< 0.001
Lead problems	40	30	< 0.001
Other	27	9

Table 3 Relationship between common primary and secondary concerns

Primary concern	No. of reports	Secondary concern
Lack of benefit	74	Battery depletion: n = 2 Generator displacement: n = 3 Electromagnetic interference: n = 7 Lead problem: n = 3 Pain: n = 43 Programming problems: n = 14 Other: n = 2
Pain or discomfort	32	Generator displacement: n = 1 Electromagnetic interference: n = 8 Lack of benefit: n = 11 Lead problem: n = 1 Pain (second type): n = 4 Programming problems: n = 5 Other: n = 2
Pocket site complications	8	Lack of benefit: n = 1 Lead problem: n = 2 Pain: n = 5
Lead problem	5	Generator displacement: n = 1 Lack of benefit: n = 3 Pain: n = 1
Programming problem	4	Electromagnetic interference: n = 2 Lack of benefit: n = 1 Pain: n = 1

Table 4 Reported interventions based on patient problems

Primary concern	Sample	Conservative therapy	Operative therapy
Lack of benefit	325	Stimulation adjusted: 160 Medication: 3 System check: 7	Explant: 22 Replacement: 17 Pocket revision: 3
Pain or discomfort	97	Stimulation adjusted: 34 Medication: 4 System check: 2	Explant: 8 Replacement: 1 Pocket revision: 7
Lead problem	70	Stimulation adjusted: 3 System check: 2	Explant: 1 Replacement: 36
Programming problems	30	Stimulation adjusted: 11	Replacement: 1

The most commonly described corrective actions are listed for key concerns addressed in the narratives. Limited or lacking information accounts for the differences between total sample size of the subgroups defined by their primary concerns.