FDA 483 - Medtronic Neuromodulation - June 30, 2017

An FDA inspection of Medtronic Neuromodulation in Minneapolis, MN, identified significant deficiencies in the firm's quality system. The company failed to adequately investigate complaints related to software revisions for the Synchromed II Pump, which led to patient overdose symptoms. Additionally, the firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with issues in verifying effectiveness and adhering to root cause identification timeframes.