# FDA 483 - Medtronic Neuromodulation - April 03, 2013

Source: https://www.keypedia.com/records/483/medtronic-neuromodulation/7b47ff0b-93fb-4cb4-996f-6e165692bb44

> FDA 483 for Medtronic Neuromodulation on April 03, 2013. Product: devices. 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: devices
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted from February 14 to April 3, 2013, at a medical device firm (name not specified in the document) located in Minneapolis, MN, revealed several significant violations of quality system regulations. Key issues included inadequate control over nonconforming products. Specifically, the firm distributed faulty SC catheters, leading to serious adverse events, and nonconforming DBS lead kits, without timely risk assessments or proper authorization for distribution. Deficiencies were also identified in the firm's corrective and preventive action (CAPA) procedures. This encompassed a failure to implement actions to prevent recurrence of quality problems, delays in completing and updating critical Health Hazard Assessments for high-priority CAPAs despite increasing adverse event complaints, and a lack of timely complaint searches. Furthermore, the inspection highlighted inadequate design controls; design verification for DBS lead caps failed to confirm specifications, and design changes for lead extensions and caps lacked sufficient testing, contributing to numerous complaints and serious adverse events. The firm is expected to promptly address these serious observations by implementing comprehensive corrective actions to ensure compliance with quality system requirements and safeguard public health.

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## Related Officers

- [Jessica L. Johnson](https://www.keypedia.com/people/jessica-l-johnson/9ea42c42-c28b-4945-a862-6b77617177f9)
- [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/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516