Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry  Klaus Bielefeldt  Autonomic Neuroscience: Basic and Clinical  Volume 202, Pages 40-44 (January 2017) DOI: 10.1016/j.autneu.2016.01.003 Copyright © 2016 Elsevier B.V. Terms and Conditions

Fig. 1 Rise in annual sale of gastric stimulators. Data summarized in summary reports of the FDA are plotted for the time between 2001 and 2014. The time frame shifted with data for 2007 covering less than a full year and data for 2014 excluding January of 2014 but reporting results for January 2015. Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Fig. 2 Bar graph summarizing perioperative complications reported in the MAUDE data base. Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Fig. 3 Bar graph depicting the most commonly reported adverse effects after implantation of gastric electrical stimulators. Findings are grouped as localized problems (black bars), complications due to system malfunction (white bars), patient complaints (dark gray bars) or description of lack or loss of efficacy (light gray bars). Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Fig. 4 Correlation between the number of reported side effects and time since GES implantation. Data are plotted for all adverse effects (white circles), adverse effects not prompting operative interventions (black circles) and those leading to corrective surgery (black squares). Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Fig. 5 Correlation between number of reported adverse effects prompting system or battery replacement and time since GES implantation. Results are plotted for all reports (white circles), reports about battery (black circles) or system replacement (black squares). Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Supplementary Fig. 1. Time between initial stimulator implantation and reported concerns for the years between 2001 and 2015; the number of reports is given in parentheses for each year. Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions

Supplementary Fig. 2. The bar graph depicts the fraction of reports about limited benefit of GES for each of the years. Autonomic Neuroscience: Basic and Clinical 2017 202, 40-44DOI: (10.1016/j.autneu.2016.01.003) Copyright © 2016 Elsevier B.V. Terms and Conditions