FDA Announces Consent Decree with Medtronic Over Alleged Quality Violations, Deal Limits Pain Pump Manufacturing and Sales

Yesterday, the Food and Drug Administration (FDA) announced the filing of a consent decree with Medtronic and two executives “for repeatedly failing to correct violations” related to the manufacture of Synchromed II Implantable Infusion Pump Systems, a medical device for chronic pain. The announcement comes after FDA had issued several Warning Letters to the company over the product—targeting the company’s insufficient quality controls and delay in correcting certain manufacturing problems. Though the decree does not come with a monetary fine, Medtronic has agreed to a long list of stringent terms regarding future business practices of the company’s neuromodulation facility.

View Medtronic’s Consent Decree

As part of the decree, Medtronic must discontinue manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems “except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment,” states FDA. 

According to the agreement, a SynchroMed device is “medically necessary” if it is used to treat: (a) severe spasticity; (b) chronic intractable pain; (c) severe chronic pain; and/or (d) primary or metastatic cancer; AND the patient’s physician signs a “Certificate of Medical Necessity,” indicating the he or she is aware of FDA’s findings related to the device.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree “will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.”

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, states FDA. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

 “The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

“Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians,” states FDA. “Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.”

Medtronic also released a press release based on the consent decree. The company states that their “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.’

Medtronic’s release also stated:

The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement.  This action is not related to Medtronic insulin pumps for diabetes. Additionally, the consent decree does not include any Medtronic businesses other than Neuromodulation. Medtronic does regularly communicate information on the performance of its products and new product safety information to physicians when available and will continue to do so in the future.

“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,” said Julie Foster, general manager and vice president, of Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business at Medtronic.