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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted electrical device intended for treatment of fecal incontinence
Regulation Description Implanted electrical urinary continence device.
Definition Treatment of chronic fecal incontinence
Product CodeQON
Regulation Number 876.5270
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
34 46 31 35 34 13

MDR Year MDR Reports MDR Events
2023 2 2
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 1 1
Output Problem 1 1
Energy Output Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 1 1
Failure of Implant 1 1
Inadequate Pain Relief 1 1
Unspecified Gastrointestinal Problem 1 1
Implant Pain 1 1
Insufficient Information 1 1

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