Medtronic Neuromodulation – FDA EIR, May 5, 2023

Medtronic Neuromodulation, located in Minneapolis, MN, underwent an FDA inspection from April 18 to May 5, 2023. This directed inspection focused on medical device recalls, corrective actions from previous inspections, and consumer complaints. The firm operates under a Consent Decree of Permanent Injunction, reflecting a history of regulatory oversight, and its medical devices are subject to the FD&C Act and 21 Code of Federal Regulations. The inspection identified four significant Written Observations. Two recalls, involving labeling changes for spinal cord stimulators regarding cardioversion and a field reset protocol for deep brain stimulators experiencing communication errors, were not reported to the FDA within the mandated 10-day timeframe, violating 21 CFR 806.10(b). Furthermore, the company's Medical Device Reporting (MDR) system was deemed inadequate for reporting malfunction incidents, and its Corrective and Preventive Action (CAPA) and complaint investigation procedures were found to be insufficiently established. Additionally, four Verbal Observations highlighted procedural deficiencies, including a lack of specificity in complaint investigation procedures, reliance on outdated documents, insufficient rationale for certain decisions, and an inadequate verification of effectiveness for a CAPA related to wireless rechargers. These findings necessitate comprehensive corrective actions from Medtronic Neuromodulation to ensure compliance with regulatory standards for medical device quality systems and reporting requirements.