FDA 483 - Medtronic Neuromodulation - November 03, 2022

An FDA inspection of Medtronic Neuromodulation, conducted from October 12 to November 3, 2022, identified two key observations related to their quality system requirements under the Federal Food, Drug, and Cosmetic Act. The first observation noted deficiencies in the company's corrective and preventive action (CAPA) procedures. Specifically, a design change to suture-less catheter connectors for Ascenda and SynchroMed II infusion pumps, initiated after 89 complaints of tissue ingrowth, was inappropriately categorized as a "correction." This classification resulted in the absence of effectiveness verification for CAPA #364661, even though the modification impacted seven catheter models.

The second observation cited Medtronic Neuromodulation for failing to report a significant correction or removal to the FDA. The company did not inform the agency about the inactivation of a third-party application on its CT900A-D Clinician Tablets. This application provided unauthorized and insecure remote-control functions for the SynchroMed II Clinician Programmer Application, posing a serious risk of patient harm, including potential overdose or underdose with a severity that could lead to death. While a "kill switch" was implemented to disable the application's icon globally, a notable number of tablets still contained the application as of October 2022.

Medtronic Neuromodulation is expected to review and rectify all identified quality system deficiencies and provide a comprehensive response to the FDA regarding these observations.