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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 7 6 2 2 3 0 0 0 0 0

MDR Year MDR Reports MDR Events
2015 5 5
2016 17 17
2017 26 26
2018 11 11
2019 6 6
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 37 37
Device Inoperable 35 35
Low impedance 17 17
Electrical /Electronic Property Problem 17 17
High impedance 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Therapeutic or Diagnostic Output Failure 8 8
Use of Device Problem 7 7
Impedance Problem 6 6
Visual Prompts will not Clear 5 5
Material Twisted/Bent 4 4
Failure to Charge 3 3
Material Distortion 3 3
Fracture 3 3
Migration or Expulsion of Device 2 2
Material Separation 2 2
Low Readings 2 2
Device Operates Differently Than Expected 2 2
Disconnection 1 1
Activation Problem 1 1
Patient-Device Incompatibility 1 1
Electrical Overstress 1 1
Battery Problem: Low Impedance 1 1
Bent 1 1
Misconnection 1 1
Material Deformation 1 1
Failure to Conduct 1 1
Connection Problem 1 1
Overheating of Device 1 1
Device Stops Intermittently 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 38 38
Therapeutic Response, Decreased 29 29
No Consequences Or Impact To Patient 16 16
Twiddlers Syndrome 6 6
Abdominal Pain 4 4
Unspecified Infection 4 4
Nausea 4 4
Vomiting 3 3
Bruise/Contusion 3 3
Perforation 2 2
Hematoma 2 2
No Known Impact Or Consequence To Patient 2 2
Seroma 2 2
Pain 2 2
Erosion 2 2
Constipation 2 2
Internal Organ Perforation 2 2
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Diaphoresis 1 1
Shock from Patient Lead(s) 1 1
Adhesion(s) 1 1
Pyrosis/Heartburn 1 1
Post Operative Wound Infection 1 1
Fever 1 1
Chills 1 1
Erythema 1 1
Swelling 1 1
Tachycardia 1 1

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