FDA 483 - Medtronic Neuromodulation - October 26, 2015

An FDA inspection conducted between August 26 and October 26, 2015, identified significant deficiencies at an unnamed medical device firm, primarily related to quality system requirements. The observations detailed in the Form FDA-483 highlight critical lapses in product control, reporting, and corrective actions.A major concern was the firm's failure to report a correction and removal to the FDA. Specifically, misleading labeling for a surgical lead, which implied unapproved "trialing" use, was discontinued in October 2014, but this action was not reported. This labeling was linked to a patient complaint where off-label use resulted in severe complications. Furthermore, the firm's website continued to display this incorrect information for months.The inspection also found that products not conforming to specifications were inadequately controlled. The firm's internal procedures for identifying, evaluating, and disposing of nonconforming products were not consistently followed, leading to instances where nonconforming materials lacked proper records, investigations were incomplete, or sold devices were not addressed after issues were identified.Additionally, the firm's corrective and preventive action (CAPA) procedures were deemed inadequate. There were instances where CAPAs were not initiated despite escalating complaint rates and high-risk classifications, contrary to the firm's own risk assessment protocols. Existing CAPAs failed to address all identified labeling issues, and recommendations from medical safety assessments for labeling changes were not escalated or implemented. Document control was also deficient, with CAPA-related investigation reports lacking dates.In response to these observations, the firm is expected to promptly develop and implement comprehensive corrective actions to bring its quality system into compliance with regulatory requirements, ensuring product safety and accurate communication.