The Food and Drug Administration (FDA) first approved the Synchromed II Implantable Infusion Pump System manufactured Medtronic, Inc. in 2004. The pump infuses pain medication, Baclofen, through a catheter into a patient’s spine. This medical device is used to treat primary or metastatic cancer, chronic pain and severe spasticity. There are approximately 271,000 devices currently on the market.
The first identified problems with these pain pumps were disclosed in 2006. Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s facilities, resulting in three warning letters notifying the company of many violations that included inadequate process for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump System, failure to document design changes, and failure to ensure that finished products meet design specifications.
In 2012, the FDA also issued a warning letter to Medtronic that cited the company for failing to correct problems with the devices. In 2013, Medtronic notified physicians of four potential defects with the pump and said that 14 deaths were associated with Synchromed II Implantable Infusion Pump System. Most of the deaths took place when patients either were deprived of medication and entered withdrawal, or after overdoses.
The Justice Department, working with the FDA, filed the consent decree of Permanent Injunction along with a legal complaint alleging that Medtronic and two of its executives have distributed “adulterated” devices. The complaint alleges that the pumps weren’t manufactured in accordance with current good manufacturing processes.
The consent decree cites violations of the quality system regulation for the medical devices which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of device which insures its safe use.
The legal action requires Medtronic to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump System except in very limited cases, such as when doctor determines that the device is medically necessary for a patient’s treatment.
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 Food and Drug Administration has determined that Medtronic has met all the provisions listed in the consent decree.
Finally, the consent decree prohibits the device from being manufactured and distributed in the United States and abroad unless and until the conduct is stopped and requires Medtronic to hire a third party expert to inspect and review its operations in its Minneapolis plant that manufactured the Synchromed II Implantable Pump System.
Patients who are implanted with Synchromed II Implantable Infusion Pump System should maintain regular follow up appointments with their doctors. Patients who experience a change or return of symptoms should contact their doctor immediately.