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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neuromodulator for obesity
Definition Weight reduction by peripheral neuromodulation.
Product CodePIM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
3 0 0 0 0 0

MDR Year MDR Reports MDR Events
2019 6 6
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
High impedance 2 2
Low impedance 2 2
Failure to Charge 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Therapeutic Response, Decreased 4 4
Pyrosis/Heartburn 1 1
Hematoma 1 1
Failure of Implant 1 1
Nausea 1 1
Pain 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1

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