# FDA 483 - Medtronic Neuromodulation - April 03, 2013

Source: https://www.globalkeysolutions.net/records/483/medtronic-neuromodulation/1d2f7c9a-e15f-44d4-9605-f8d0800c7f03

> FDA 483 for Medtronic Neuromodulation on April 03, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Neuromodulation
- Inspection Date: 2013-04-03
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Medtronic Neuromodulation in Minneapolis, MN, was cited for significant quality system deficiencies during an FDA inspection. The firm distributed nonconforming medical devices, including SC catheters and DBS lead kits, which resulted in serious adverse events and numerous complaints. Additionally, the inspection revealed inadequate corrective and preventive action procedures, failures in design verification, and insufficient design change controls.

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## Related Officers

- [Jessica L. Johnson](https://www.globalkeysolutions.net/people/jessica-l-johnson/9ea42c42-c28b-4945-a862-6b77617177f9)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

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

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