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After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps

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Medtronic Must Stop Selling Synchromed Drug Pumps

Medtronic Must Stop Selling Synchromed Drug Pumps


Medtronic must stop selling the majority of its implantable drug pumps due to years of unfixed problems, the U.S. Food and Drug Administration (FDA) said. Star Tribune reports that the agency has filed a court order stating that Medtronic must stop distributing and producing its Synchromed II drug pumps. The devices are surgically implanted to delivery a drug solution in the area surrounding the spine in patients with cancer, chronic pain and severe muscle spasms. The pumps were recalled because they may lose battery power and fail, causing harm to patients. The devices were also problematic in cases where they delivered the wrong amount of medication. Even though Medtronic has been aware of problems since 2006, they have failed to act; this lack of compliance has prompted to the FDA more aggressively assert its authority.

The FDA is waiting on the signature of a federal judge on its consent decree, which is a type of legal settlement where a company complies with court-ordered action without admitting fault or guilt. The consent decree, which was filed in the U.S. District Court of Minnesota, doesn’t say Medtronic is admitting liability, but it does halt most sales and manufacturing of the device until the FDA decides that the company has addressed the problems first documented in 2006.

Medtronic must comply with the decree until the FDA decides the company has corrected the problems outline in the document. “Defendants are well aware that their practices violate the Act,” FDA said in the filing. “FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct.”

Star Tribune reports that from 2006 through 2013, the FDA issued three warning letters to Medtronic for quality control and manufacturing issues at its drug pump facility in Columbia Heights, Minnesota. The agency stated on Monday that inspectors visited the plant on five different occasions during that period.

breakinglawsuitnews.com disclaimer: This article: After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps was posted on Wednesday, April 29th, 2015 at 1:40 am at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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