Pending approval from U.S. district court in Minnesota, Medtronic Plc agrees to consent decree with the FDA regarding its SynchroMed implantable drug pump. The company will correct problems that cause the pumps to deliver either too little or too much medication. The pumps are used for treating cancer and chronic pain patients and those with severe muscle spasms. The pain medications are delivered directly into the cerebrospinal fluid.
It was during FDA inspections between 2006 and 2013 that the issues with product quality were discovered. The issues included design controls and complaint handling. The Department of Justice filed a complaint shortly thereafter.
The consent decree was agreed to by Medtronic and two top executives and requires the company to make necessary changes to its manufacturing processes. The top executives are Medtronic’s CEO, Omar Ishrak, and the head of the neuromodulation division that produces the pumps, Thomas Tefft.
If the court approves the consent decree, Medtronic will stop manufacturing and distributing SynchroMed pumps unless a doctor certifies that it is a medically necessary device. Medtronic will also hire an expert to assist it in correcting the regulatory violations. Currently, patients using the pump do not have to change any part of their therapy or have the pumps removed.
Medtronic issued a statement saying its focus is on making the necessary design changes and improving the quality system for its neuromodulation products. The company, based in Ireland with an operating location in Minnesota, is the world’s largest stand-alone medical device manufacturer.
The consent decree is a type of settlement in which Medtronic agrees to certain court-ordered actions but does not admit guilt or fault. The decree will stand until the FDA is satisfied that the company has remedied the issues.