FDA 483 - Medtronic Neuromodulation - May 05, 2023

Medtronic Neuromodulation, located in Minneapolis, MN, underwent an FDA inspection from April 18 to May 5, 2023. The resulting Form 483 detailed four major areas of concern regarding the company's quality systems and safety reporting for its implantable neurostimulation devices. A primary violation involved the failure to notify the FDA within the required 10-day timeframe regarding product corrections and removals. Specifically, the company updated product labeling and initiated field resets to address electrical damage and communication failures but did not report these actions as required. Additionally, the FDA found that Medtronic's internal procedures for reporting medical device malfunctions were inadequate, leading to delays in reporting significant events, such as patient burns during device recharging. The inspection also highlighted deficiencies in the company's Corrective and Preventive Action (CAPA) processes. Medtronic failed to timely extend corrective measures to all affected product families even after confirming similar risks across different models and failed to address all identified root causes. Furthermore, the firm did not adequately investigate new complaints, often relying on outdated studies that did not apply to newer device designs. These observations were issued under the Federal Food, Drug, and Cosmetic Act. While the document is not a final determination of compliance, it serves as a formal notice of objectionable conditions. Medtronic has promised to correct all noted deficiencies and is responsible for conducting internal audits to ensure the long-term effectiveness of these corrective actions.