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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
Definition As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation.
Product CodeSAZ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 0 2 4 0

MDR Year MDR Reports MDR Events
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Break 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Shock from Patient Lead(s) 1 1
Discomfort 1 1

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