NWCDN Members regularly post articles and summary judgements in workers’ compensations law in your state.
Select a state from the dropdown menu below to scroll through the state specific archives for updates and opinions on various workers’ compensation laws in your state.
Contact information for NWCDN members is also located on the state specific links in the event you have additional questions or your company is seeking a workers’ compensation lawyer in your state.
On May 3, 2015, the U.S. Food and Drug Administration announced the filing of a consent decree against Medtronic, Inc. for repeatedly failing to correct violations related to the manufacture of Synchromed II Implantable Infusion Pump Systems. The consent decree cites violations of the quality system regulation for medical devices, and requires the company to stop manufacturing, designing, and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases. The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations.
The FDA first identified problems with the manufacture of these pumps in 2006, including over-infusion, under-infusion, and delays in therapy for patients. The FDA issued three warning letters notifying the company of major violations, including inadequate processes for identifying, investigating, and correcting quality problems, failure to document design changes, and failure to ensure the finished products met design specifications.
The agency notes that patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians, and should contact their physician immediately if they experience a change or return of symptoms, or hear a device alarm.