FDA WARNING_LETTER - Medtronic Navigation, Inc - February 04, 2010

On January 2 - February 4, 2010, an FDA inspection of Medtronic Navigation, Inc. in Louisville, Colorado, identified significant deviations from the Federal Food, Drug, and Cosmetic Act for their Class II image-guided surgical systems.

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(2))**: In 2009, (b)(4) software defects were "Open, not assigned" without disposition, and lacked "Severity," "User Impact," and "Probability of Harm" fields as required by SOP-C-1010 Rev 4. 2. **Failure to establish and maintain design validation procedures, including risk analysis (21 CFR 820.30(g))**: The "StealthStation Hazard Analysis Report" for the Treon StealthStation failed to define an acceptable risk level. 3. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)(3))**: A complaint (b)(4) describing a 1.5 cm image inaccuracy during surgery, where a bur hole was drilled incorrectly, was not submitted as an MDR reportable event. A similar deviation was noted in a previous inspection. Additionally, two device failures in the customer tracking system were not considered complaints. 4. **Failure to establish