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

Source: https://www.keypedia.com/records/warning_letter/medtronic-navigation-inc/69eff621-2835-4eda-9597-f65826e7eae7

> FDA WARNING_LETTER for Medtronic Navigation, Inc on February 04, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Medtronic Navigation, Inc
- Inspection Date: 2010-02-04
- Product Type: Devices
- Office Name: Denver District Office
- Summary: 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

## Related Officers

- [H.](https://www.keypedia.com/people/thomas-warwick/62a2152a-d2c5-4362-bd12-f90807ff0b26)
- [Senior Advisor](https://www.keypedia.com/people/james-l-cloar-iii/cf9a09b5-610d-4c2f-92cd-1c84b036a651)

Company: https://www.keypedia.com/companies/medtronic-navigation-inc/98dc1d17-468f-4daf-b611-5d17253f6f99

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face