# FDA 483 - Medtronic Navigation, Inc.-Boxborough - January 03, 2018

Source: https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/05b55678-dd94-459b-9eab-c9260f65d46c

> FDA 483 for Medtronic Navigation, Inc.-Boxborough on January 03, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Navigation, Inc.-Boxborough
- Inspection Date: 2018-01-03
- Product Type: devices
- Office Name: New England District Office
- Summary: During an FDA inspection conducted from December 5, 2017, to January 3, 2018, Medtronic Navigation, Inc.-Littleton was issued a Form FDA 483 outlining seven observations of non-compliance. The primary concerns revolved around deficiencies in post-market surveillance, quality system documentation, and electronic product radiation control for their O-Arm 1000 and O-Arm O2 Imaging Systems. Key violations included the failure to report a field corrective action for 26 O-Arm 1000 units, which involved a software update to address shutdowns during surgical procedures, to the FDA. The company also inadequately documented corrective and preventive actions for nonconforming products. Furthermore, Medtronic failed to submit Medical Device Reports (MDRs) within the mandated 30-day timeframe for several adverse events, and did not report accidental radiation occurrences when additional imaging spins led to increased patient radiation exposure. Critical regulatory submissions were also overlooked, as the firm failed to submit annual reports and product reports for devices containing laser components prior to commercial introduction, and did not maintain records of electronic product radiation safety tests. These observations indicate deviations from the Federal Food, Drug, and Cosmetic Act and related regulations for medical devices. Medtronic Navigation, Inc. committed to correcting all identified issues, necessitating a comprehensive review and enhancement of their reporting, documentation, and compliance procedures to ensure product safety and regulatory adherence.

## Related Documents

- [483 - 2018-01-03](https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/05dcd2b4-f338-4514-9acc-4e43ae7453a1)
- [483 - 2024-06-11](https://www.keypedia.com/records/483/medtronic-navigation-inc-boxborough/f91e4756-dec0-4a2e-95d1-596eee37f06c)

## Related Officers

- [Quality Engineering Director](https://www.keypedia.com/people/john-m-castellano/5841c5c5-d50e-4385-9c5a-e22caa44cb47)
- [FDA_PERSONNEL](https://www.keypedia.com/people/nabil-nakhoul-investigator/9cef9331-6826-4fd2-87a8-c9d9d8c35479)

Company: https://www.keypedia.com/companies/medtronic-navigation-inc-boxborough/e864dd74-6f9e-4fc1-a677-017f22994700

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144