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

- Voluntary reporting of adverse events after stimulator implantation are common.
- Most adverse events focus on lack of benefit or pain due to the stimulator or stimulation.
- More than one third of the adverse events prompt surgical correction.

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.MethodsWe conducted an electronic search of the Manufacturer and User Device Experience (MAUDE) databank using the keyword 'Enterra' for the time between January of 2001 and October of 2015. We abstracted information about the year of stimulator implantation, the year and type of adverse effect, the resulting intervention and outcome if available.ResultsA total of 1587 entries described adverse effects related the GES. Only 36 of the reports listed perioperative complications. The vast majority described problems that could be classified as patient concerns, local complications, or system failure. The most common problem related lack or loss of efficacy, followed by pain or complications affecting the pocket site. A subset of 801 reports provided information about the time between system implant and registration of concerns, which gradually declined over time. More than one third (35.7%) of the reported adverse events prompted surgical correction.ConclusionThe number of voluntarily reported adverse events and the high likelihood of repeated surgical interventions clearly demonstrate the potential downside of gastric electrical stimulation. Physicians considering this intervention will need to carefully weigh these risks and include this information when counseling or consenting patients.