May 22, 2015 — After years of failing to fix safety problems linked to at least 14 deaths, the FDA has ordered Medtronic to stop selling SynchroMed infusion pumps.
The FDA filed a consent decree on April 27, which is a type of legal settlement in which a company agrees to take certain actions but does not admit guilt.
Medtronic has agreed to stop making, designing, and selling SynchroMed infusion pumps except in very rare circumstances, such as when a doctor says it is necessary for a patient’s care.
The SynchroMed infusion pump was initially approved in 2004. Since then, four Class I recalls have been issued for various life-threatening safety defects — mostly involving problems that could lead to over-infusion or under-infusion of medications, including powerful painkillers.
The pump is often implanted in patients suffering from chronic pain. It is designed to be implanted near a patient’s spine, where a battery-powered motor slowly delivers tiny amounts of medications to help treat conditions like spastic muscles and back pain.
In 2006, Medtronic discovered manufacturing defects. From 2006 to 2013, the FDA sent Medtronic three warning letters describing “major violations” discovered during five inspections. There are many examples of serious problems:
- February 2011 — A recall was issued after nearly 300 people were injured and 8 died from overdoses when doctors mistakenly injected painkillers directly into the patient instead of the infusion pump.
- September 2011 — Another recall was issued because the batteries could fail prematurely.
- August 2012 — The FDA sent Medtronic a Warning Letter after finding that the company knew as early as October 2007 that corrosion problems could cause the pump to fail, but they failed to fix the problem. The FDA received 567 complaints about corrosion.
- June 2013 — At least 14 deaths have been linked to the SynchroMed pumps since 1996, according to Bloomberg. Most of the deaths involve overdoses or under-doses of medications.
- And more
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