Adverse events of gastric electrical stimulators recorded in the Manufacturer and User Device Experience (MAUDE) Registry

The role of gastric electrical stimulation for patients with refractory symptoms of gastroparesis remains controversial. Open label studies suggest benefit while randomized controlled trials did not demonstrate differences between active and sham intervention. Using a voluntary reporting system of the Federal Drug Administration, we examined the type and frequency of adverse events.We conducted an electronic search of the Manufacturer and User...