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1206222

Medtronic Neuromodulation — FEI 2182207

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 5, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Minneapolis, MN (United States)

Facility

Other inspections at this facility

  • 1187313 (VAI Thu Nov 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153966 (NAI Thu Sep 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108789 (VAI Thu Oct 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102180 (NAI Tue Aug 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059011 (NAI Thu Jun 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
419321 CFR 806.10(b)Time to report - 10 days
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations