FDA 483 - Medtronic MiniMed, Inc. - March 14, 2018

Medtronic Inc. in Northridge, CA, was cited for significant deficiencies in its medical device reporting and complaint handling processes. The firm failed to submit thousands of Medical Device Reports within the required 30-day timeframe and did not adequately review, evaluate, or investigate complaints involving potential device failures that led to adverse events or serious injuries. These issues indicate a systemic problem with post-market surveillance and quality system compliance.