FDA 483 - Medtronic Neuromodulation - January 24, 2007

An FDA inspection of Medtronic Neurological, conducted from November 2006 to January 2007, revealed several critical quality system deficiencies. The company's risk analysis for SynchroMed pumps and intrathecal catheters was found incomplete, notably failing to identify inflammatory mass, granuloma, or fibrosis as potential hazards, contrary to their own procedures. Corrective and preventive action (CAPA) procedures were inadequately implemented; numerous product comment reports (PCRs) detailing serious adverse events, such as paralysis and subarachnoid hemorrhage, were not properly evaluated, ranked, or closed without adequate investigation or risk assessment. Furthermore, Medtronic failed to adhere to complaint handling protocols, neglecting to process relevant medical and scientific literature for potential Medical Device Reporting (MDR) evaluation. The inspection also highlighted a lack of supporting data for claims of reduced inflammatory mass incidence, with actual reported rates significantly higher than previously communicated. The firm had not fully identified all necessary actions to address ongoing quality issues, including previously mishandled adverse events. Crucially, many serious adverse events reported by healthcare professionals, patients, or family members were not submitted as MDRs within the required timeframe. Additionally, a significant customer communication in July 2003 regarding inflammatory masses, including revised labeling, was not reported to the FDA as a correction or removal. Medtronic committed to correcting these observations.