# FDA 483 - Medtronic Neuromodulation - June 30, 2017

Source: https://www.keypedia.com/records/483/medtronic-neuromodulation/54b630ae-a2e2-454e-ba6e-55435aca525c

> FDA 483 for Medtronic Neuromodulation on June 30, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Neuromodulation
- Inspection Date: 2017-06-30
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Medtronic Neuromodulation in Minneapolis, MN, identified significant deficiencies in the firm's quality system. The company failed to adequately investigate complaints related to software revisions for the Synchromed II Pump, which led to patient overdose symptoms. Additionally, the firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with issues in verifying effectiveness and adhering to root cause identification timeframes.

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## Related Officers

- [Investigato](https://www.keypedia.com/people/joey-c-west/4ecce3be-9f8f-40eb-a7ff-0364f5864bfa)
- [investigator](https://www.keypedia.com/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

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