FDA 483 - LivaNova USA Inc. - July 25, 2008

An FDA inspection conducted from July 22-25, 2008, at Sorin Group USA, Inc., a medical device manufacturer in Arvada, CO, identified significant deficiencies in the firm's complaint handling and reporting processes. The primary observation highlighted that the company failed to implement adequate procedures to evaluate all complaints for potential Medical Device Report (MDR) filing. Specifically, a review of eleven complaints from January 2008 revealed that Sorin Group USA, Inc. did not follow its own Standard Operating Procedure for Medical Device Reporting. Several instances, including complaints detailing substantial blood loss during cardiac bypass procedures and a case involving patient hematuria, were not properly assessed or reported to the FDA as required by regulatory frameworks governing medical device safety. These lapses indicate a need for improved internal controls to ensure compliance with medical device reporting regulations. The company committed to correcting these identified issues within four weeks of the inspection. This FDA 483 document serves as a formal notification of these observations, requiring prompt and effective corrective action to ensure public health protection and regulatory adherence.