FDA 483 - Medtronic Neuromodulation - October 17, 2019

An FDA inspection of Medtronic Neuromodulation in Minneapolis revealed two significant issues. The firm failed to adequately document design input requirements for interchanging programmer applications, which led to patients experiencing excessive stimulation and pain. Additionally, procedures for corrective and preventive actions related to suppliers were not properly established, with multiple CAPAs lacking essential quality records for various phases.