# FDA 483 - Medtronic Neuromodulation - June 15, 2026

Source: https://www.keypedia.com/records/483/medtronic-neuromodulation/d9c45d96-7bec-402c-8bc2-112cc6d0b4b5

> FDA 483 for Medtronic Neuromodulation on June 15, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Neuromodulation
- Inspection Date: 2026-06-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Medtronic Neurological in Minneapolis, MN, revealed significant deficiencies in their quality system related to medical device manufacturing. The firm failed to adequately implement procedures for design input, design validation, and process validation for their 8731 Intrathecal Catheters. Additionally, issues were found in production process control, the effectiveness of corrective and preventive actions, maintenance of device history records, and the completeness of medical device reports.

## Related Documents

- [EIR - 2023-05-05](https://www.keypedia.com/records/eir/medtronic-neuromodulation/9a2a8d83-b947-44bc-8aae-b9c5c427fac7)
- [483 - 2007-01-24](https://www.keypedia.com/records/483/medtronic-neuromodulation/4ed7e9e9-c2c3-4dd5-9bb9-d44ecb4018c4)
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- [483 - 2011-01-21](https://www.keypedia.com/records/483/medtronic-neuromodulation/7e95409e-32e3-484c-8da1-1e86ce0604f4)
- [483 - 2012-05-09](https://www.keypedia.com/records/483/medtronic-neuromodulation/86b7cddb-fe97-4e72-b7c1-ac6992059027)

## Related Officers

- [Kellie L. Westerbuhr](https://www.keypedia.com/people/kellie-l-westerbuhr/80b04def-a227-4189-947a-ce3565c47642)
- [Timothy G. Philips](https://www.keypedia.com/people/timothy-g-philips/ab522f00-8e56-42e4-92b6-55d5f1a4a65b)

Company: https://www.keypedia.com/companies/medtronic-neuromodulation/2a0b2563-ee1c-4a97-a37a-e714223e0f65

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d