Medtronic in Trouble with FDA over SynchroMed II Drug Pumps

The Food and Drug Administration has issued a warning letter and requested a meeting with officials from Medtronic Inc. regarding its defective SynchroMed II drug infusion pump.

These infusion pumps are used to deliver painkiller and other drugs into patients on a regular or prolonged basis. The SynchroMed II is approved to deliver morphine sulfate, ziconotide, and baclofen in the treatment of severe and chronic pain. Patients suffering from forms of cancer also use the pumps to deliver floxuridine and methotrexate.

Problems with the SynchroMed II pumps were first discovered in 2007. Corrosion of the pumps caused the motors to stall and seize, resulting in device failure, meaning it stopped delivering drugs to the patient. In some instances, if the problem was not noticed, it could result in life-threatening circumstances.

Medtronic nearly has the market cornered on drug infusion pumps, so the FDA is very interested in ensuring the manufacturer is aware of problems associated with it and has plans in place to take immediate action when necessary. The company’s failings in this area have prompted the need for a review of the company’s processes and what it’s doing to prevent future problems.

Five years later, the FDA believes Medtronic has not addressed the problem and these infusion pumps continue to fail due to the same problems. In all, the agency has 567 complaints on record involving the SynchroMed II infusion pump. Inspectors representing the FDA visited the SynchroMed II manufacturing facility at Medtronic and discovered that the company had not yet addressed the corrosion problems with the pumps.

According to a Bloomberg report this week, the FDA issued a warning letter to Medtronic recently and has requested a meeting with the company’s neuromodulation unit to find out what it plans to do in addressing the failures of the SynchroMed II pumps. The company did issue a plan to the agency on how it will deal with monitoring and evaluating complaints regarding reported device failures.

The FDA is requesting an independent review of Medtronic’s handling of device failures involving the SynchroMed II pumps, specifically. Previous efforts by the company to notice signs of drug withdrawal and increased pain suffered by patients caused by the device’s battery failing prompted a review of Medtronic’s mitigation of problems. This eventually led to a recall on the SynchroMed II pump’s battery last year.  The company had issued a similar recall on the pump battery in 2009 for the same problem.

Medtronic now markets a newly-approved battery with the same infusion pump but has yet to address problems with the motors seizing and stalling.

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