Medtronic has entered into a consent decree with federal regulators for repeated errors and manufacturing problems involving the Synchromed II Implantable Infusion Pump Systems.
The consent decree was announced by the FDA on Monday, and requires the company to cease manufacturing, designing and distribution of new Medtronic Synchromed II infusion pumps, except in cases where a doctor determines it is medically necessary for a patient’s treatment.
The FDA accuses Medtronic and two of the company’s officers, S. Omar Ishrak and Thomas M. Tefft, of repeatedly failing to address manufacturing violations.
In addition to the halt of manufacturing, Medtronic must also retain a third-party expert to help develop plans to correct the violations. The consent decree will remain in effect until the FDA is satisfied that all of the Medtronic Synchromed problems have been addressed.
The SynchroMed Infusion Pump line has been plagued by issues over the last several of years. In February 2011, the FDA declared a Class I Medtronic Synchromed pump recall following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.
In September 2011, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. The FDA classified that as a Class I recall as well. Class I medical device recall classifications mean that the FDA believes the device has a reasonable likelihood of causing severe injury or death.
In July 2012, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.
The FDA press release states that the agency conducted five inspections between 2006 and 2013, which led to a total of three warning letters for major violations. Those violations involved failures to create processes for dealing with quality control problems. The company also failed to document design changes and make sure that the products it shipped out met design specifications.
“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” Jan Welch, acting director of the Office of Compliance in the FDA Center for Devices and Radiological Health, said in the press release. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”