Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther 2016; 7(2): 294-305 [PMID: 27158546 DOI: 10.4292/wjgpt.v7.i2.294]
Corresponding Author of This Article
Klaus Bielefeldt, MD, PhD, Division of Gastroenterology, University of Pittsburgh Medical Center, 200 Lothrop St. Pittsburgh, PA 15217, United States. bielefeldtk@upmc.edu
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Systematic Reviews
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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
Citation: Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther 2016; 7(2): 294-305