Clark, Love & Hutson, GP

FDA orders Medtronic to stop selling Synchromed drug pumps

For many Houston residents modern medicine has helped tremendously. There are so many more options available these days for those suffering from serious medical conditions. Medical device manufacturers have come up with life-saving devices that increase quality of life for millions of people. But occasionally there are defective medical devices that can do more harm than good.

The FDA is ordering Medtronic to stop selling most of their Synchromed drug pumps. The pumps are an implant device that treat patients with cancer, pain and muscle spasms. They are implanted near the spinal column and deliver the medication to patients who do not respond well to oral medications or who experience side effects from oral medications. The pumps have been shown to lose battery power and fail. This could lead to serious injuries for patients by giving them too much medication or too little medication.

The FDA filed a decree with the U.S. District Court of Minnesota. It alleges that Medtronic sold medical devices that failed to meet federal safety standards. A consent decree means a company will agree to court-ordered arrangements but will not admit fault. Medtronic will need to hire outside experts to fix the problems pointed out in the decree.

If a patient believes they have been harmed by a defective medical device they may want to speak with a legal professional skilled in medical devices. An attorney can review the patient's medical records and research the medical device to find out who is responsible for the injury.

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