Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Material Distortion 3 3
Fracture 3 3
Failure to Charge 3 3
Migration or Expulsion of Device 2 2
Low Readings 2 2
Material Separation 2 2
Device Operates Differently Than Expected 2 2
Electrical Overstress 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Battery Problem: Low Impedance 1 1
Material Deformation 1 1
Activation Problem 1 1
Device Stops Intermittently 1 1
Improper or Incorrect Procedure or Method 1 1
Bent 1 1
Misconnection 1 1
Overheating of Device 1 1
Loose or Intermittent Connection 1 1
Failure to Conduct 1 1
Disconnection 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
Unspecified Infection 4 4
Nausea 4 4
Abdominal Pain 4 4
Bruise/Contusion 3 3
Vomiting 3 3
No Known Impact Or Consequence To Patient 2 2
Constipation 2 2
Erosion 2 2
Hematoma 2 2
Internal Organ Perforation 2 2
Pain 2 2
Perforation 2 2
Seroma 2 2
Swelling 1 1
Tachycardia 1 1
Adhesion(s) 1 1
Erythema 1 1
Fever 1 1
Pyrosis/Heartburn 1 1
Shock from Patient Lead(s) 1 1
No Code Available 1 1
Chills 1 1
Post Operative Wound Infection 1 1
Diaphoresis 1 1
Patient Problem/Medical Problem 1 1

-
-