FDA bans manufacturing of Medtronic's infusion pump, citing violation of quality system regs

SynchroMed infusion pump--Courtesy of Medtronic

The FDA halted the manufacture of Medtronic's ($MDT) SynchroMed II Implantable Infusion Pump Systems, citing repeatedly failing to correct violations of the agency's quality system regulations in a consent decree filed against company CEO Omar Ishrak and Senior Vice President Thomas Tefft.

Under the terms of the agreement Medtronic must retain a third-party expert to help correct the violations of FDA's regs that occurred at its Columbia Heights, MN, facility. The ban on manufacturing, designing and distributing the device for delivering medication to treat primary or metastatic cancer, chronic pain and severe spasticity will last until the FDA determines that all conditions of the decree have been met.

An exception to the ban will be permitted if a doctor determines that the device is medically necessary to treat a patient. Competitor Flowonix makes the Prometra Implantable Pump System.

Medtronic must submit audit reports once manufacturing resumes and will be subject to FDA inspections, the agency said in its statement. Five inspections conducted between 2006 and 2013 resulted in three warning letters for violations like inadequate correction of quality problems, failure to document design changes, and failure to ensure that finished products meet design specifications, the FDA statement says.

"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's device arm (CDRH), said in a statement. "We will continue to stop distribution of devices made by firms that fall short of regulatory requirements."

Medtronic said the consent decree does not require retrieval of any existing SynchroMed pumps or affect any patients using the device currently. It is not the result of any new safety information about the device.

"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," said Tefft, president of the company's neuromodulation unit. "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."

The device's safety problems are responsible for 14 deaths since 1996. In December 2012 the company sent a letter to customers warning that use of unapproved drugs with its SynchroMed pumps can more than double the rate of device failure.

The FDA's recall database shows that the device has been subject to a whopping 30 Class I recalls. They occurred between 2006 and 2013, with more than half of the recalls taking place in 2008.

Class I recall are reserved for cases in which the FDA believes there is a reasonable probability that the device "will cause serious adverse health consequences or death."

- read the FDA statement
- here's Medtronic's release