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FDA Comes Down on Medtronic over Infusion Pump Faults

The agency has filed a consent decree against the company and two of its two executives.

Qmed Staff

SyncroMed II
The Syncrhomed II device has been cited in a number of Class I recalls in recent years.

An FDA consent decree alleges that Medtronic has repeatedly failed to address manufacturing problems related to its Synchromed II implantable infusion pump.

First approved in 2004, the device can sometimes inaccurately deliver medication or delay its delivery.

FDA inspections of the company's facilities in Columbia Heights, MN have reported major violations. Carried out from 2006 and 2013, FDA's inspections of those facilities resulted in three warning letters, which stated that the firm did not follow good manufacturing processes for corrective and preventive action (CAPA), design controls, and complaint handling. In particular, the warning letters state that the company did not have an adequate process for identifying quality problems, failing to document design changes, and failing to ensure that the finished product complied with design specifications. The problems were said to be unresolved for years.

Used for patients suffering from cancer, chronic pain and severe muscle spasms, the Synchromed II device has also been mentioned in several Class I recalls in recent years, which have cited battery, labelling, and electrical problems related to the device.

The consent decree, which named the company's CEO, Omar Ishrak, and senior vice president, Thomas Tefft, requires Medtronic to halt the manufacture and distribution of Synchromed II pumps except for limited exceptions. It was filed in the U.S. District Court of Minnesota.

The decree also stipulates that Medtronic hire a third-party expert to correct manufacturing violations. Once such problems are resolved, the company can resume manufacturing and distribution of the devices, but is required to submit audit reports to the agency.

In a statement, Medtronic noted that "[p]atients with the Synchromed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement."

In addition, Medtronic has also set up a dedicated website related to the consent decree with FDA, located at http://facts.synchromed.com.

Medtronic's stock ticked down $1.40, or 1.8%, on Monday to $76.21.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.
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