UPDATED April 28, 2015, with details of consent decree.
The ban applies to SynchroMed II except in cases where a doctor deems it essential, the FDA said, and Medtronic must hire an outside expert to develop a plan to correct the violations. The consent decree will only be lifted once it determines that Medtronic has corrected the problems, at which time the company can begin making the SynchroMed II device again, the agency said.
"Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections," the FDA said.
"The FDA expects that all patients will be treated with safe, effective and high-quality medical devices. We will continue to stop distribution of devices made by firms that fall short of regulatory requirements," added Jan Welch, acting director of the Office of Compliance for the FDA’s Center for Devices & Radiological Health. The agreement includes CEO Omar Ishrak and Thomas Tefft, head of the neuromodulation division that makes the pumps.
Regulators in jurisdictions including the U.S., the U.K. and Hong Kong have issued a series of warnings in recent years about the SynchroMed device, which is designed to deliver medication directly to the intrathecal space around the spinal cord. It’s indicated to treat chronic, intractable pain, severe spasticity and cancer, Medtronic said.
In July 2011 Medtronic warned that some of its SynchroMed II pumps may have defective batteries that could result in sudden device failure. By the time the warning was made public more than 50 confirmed battery defect failures had occurred. The battery issue spurred an FDA Class I recall.
The devices were subject to yet another Class I recall in December 2012, when Medtronic said it had received reports of higher-than-expected rates of failure when the implantable SynchroMed II pumps were used with "unapproved drugs." In April 2012 the U.S Court of Appeals for the 9th Circuit upheld a lower court’s ruling dismissing a personal injury lawsuit case on preemption grounds.
Medtronic said the consent decree does not involve a recall for any product or require current SynchroMed II patients to change their treatment or remove the device.
"The company’s efforts are focused on the implementation of design changes to the SynchroMed drug infusion pump to address issues the company has previously communicated, and on enhancing the neuromodulation quality system. The agreement also includes a defined process by which Medtronic can continue to provide physicians with access to the SynchroMed drug infusion system for patients," the company said.
"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA’s expectations," Tefft said in prepared remarks. "We are confident that our efforts to date will contribute to the timely and thorough completion of these activities while preserving access to this important therapy in the interest of patients, their caregivers and physicians."
"We take our responsibility to ensure continued support for clinicians and their patients who rely on this important treatment option very seriously, and we are committed to working collaboratively with the FDA to address their expectations as quickly as possible," added vice president Julie Foster.
Material from Reuters was used in this report.