The U.S. Food and Drug Administration sent a warning letter to medical device maker Medtronic, saying it lacks adequate complaint procedures and its response to complaints and an FDA investigation were inadequate. Medtronic manufactures implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products and other neurological medical/surgical products.
The devices in question are intended to deliver drugs and stimulation to the brain and spinal cord, similar to how cardiac pacemakers work, to treat a variety of ailments including Parkinson’s disease and chronic pain.
The FDA told Medtronic in a letter dated July 17, 2012, that regulatory action might ensue should the manufacturer fail to address the agency’s request to take action. The FDA also told the company that it will not approve any device in question unless Medronic addresses its concerns properly.
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