FDA 483 - Medtronic Neuromodulation - April 03, 2013

Medtronic Neuromodulation in Minneapolis, MN, was cited for significant quality system deficiencies during an FDA inspection. The firm distributed nonconforming medical devices, including SC catheters and DBS lead kits, which resulted in serious adverse events and numerous complaints. Additionally, the inspection revealed inadequate corrective and preventive action procedures, failures in design verification, and insufficient design change controls.