A recent Wall Street Journal report found that 14 deaths were tied to Medtronic's SynchroMed drug-infusion pumps. The Department of Justice (DOJ), in conjunction with the Food and Drug Administration (FDA), filed a consent decree and a legal complaint alleging that medical device maker, Medtronic, has distributed faulty SynchroMed drug-infusion pumps. The complaint alleges the pumps were not manufactured with current Federal good manufacturing practices and notes that the devices have been linked to serious injuries and deaths in recent years.
Federal authorities reached a proposed consent agreement with Medtronic over the SynchroMed drug-infusion pump defects. The pump is used in treating cancer, severe chronic spasticity and to distribute pain medicine. When patients do not respond well to oral medication or suffer from severe side effects they may be treated with a medication pump.
The DOJ and FDA complaint claims Medtronic distributed contaminated devices and that the pain pumps were not manufactured in accordance with good manufacturing practices. More specifically, Medtronic repeatedly failed to correct violations of FDA quality regulations. Through two different inspections the government uncovered significant violations of quality regulations.
Under the proposed agreement, Medtronic will stop manufacturing and distributing new versions of the SynchroMed II implantable pump except in extraordinary cases. Medtronic will resume full distribution of the pump system only with permission from the FDA.
The FDA warned Medtronic three times about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota. The FDA issued a warning to Medtronic in 2012, which cited the company for failing to correct problems with the devices. Motor corrosion, which leads to a failure to deliver medication, was among one of the devices problems.
The pump system produced by Medtronic has been used in more than 230,000 patients since it was approved over 25 years ago. Medtronic notified physicians of 14 deaths associated with SynchroMed from 1996 through April 2013. The deaths arose from four potential defects with the pump which led to medication deprivation producing withdrawal, or overmedication causing overdose. The four issues with the device were classified as Class 1 recalls by the FDA, i.e., they can lead to serious injury or death. The proposed agreement will become final after a federal judge signs off on the terms. The proposed agreement was filed in U.S. District Court in Minnesota.