Intestinal Stimulator
FDA adverse event reports and recall history for intestinal stimulator (product code LNQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 4,367
- Deaths
- 73
- Injuries
- 2,924
- Malfunctions
- 1,344
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-10-29TerminatedDevice Design
Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical intervention (all patients recovered withou
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