In compliance with a consent decree filed by the U.S. Food and Drug Administration (FDA), Medtronic has agreed to stop production and distribution of Synchromed II drug pumps, except in special cases. The problem with the defective pumps is that they can deliver too much or too little medication, or patients may experience delayed therapy. The action comes after Medtronic failed to correct known problems with the device. There will not be a recall existing devices.
Synchromed II Drug Pumps
Synchromed II drug pumps are used to treat primary or metastatic cancer, chronic pain and severe spasticity. The pump is implanted in the body and delivers pain medication directly to the spinal cord area. They are used in patients who either do not respond or experience severe side effects when using oral pain medications.
Medtronic will still be allowed to provide the pumps on a limited basis in extreme circumstances when a physician certifies that it is medically necessary for a patient.
This is not a recall. If you already have one of these pumps implanted in your body, the FDA recommends maintaining regular follow-up appointments with your doctor, and says that you should call your doctor immediately if your symptoms change or return or if you hear a device alarm.
A Known Problem for Nearly a Decade
The FDA first identified problems with in 2006. There were five FDA inspections between 2006 and 2013 and they resulted in three warning letters to Medtronic about major violations.
Medtronic failed to correct the violations, but was allowed to continue producing and selling the potentially defective pumps for nearly 10 years before it was ordered to stop doing so until it corrects the problem.
The Future of the Pump
Medtronic is required to stop manufacturing, designing and distributing the Synchromed II Implantable Infusion Pump Systems until it corrects violations of the quality system regulation for medical devices. The company is required to hire a third-party expert to help it develop and submit plans to make these corrections.
When it does get permission to start making the pumps again, Medtronic will be required to submit reports to the FDA showing compliance and the FDA says it will conduct its own inspections as well.
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