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TPLC
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show TPLC since
2009
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Device
neuromodulator for obesity
Definition
Weight reduction by peripheral neuromodulation.
Product Code
PIM
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
Failure to Charge
3
3
Fracture
3
3
Migration or Expulsion of Device
2
2
Low Readings
2
2
Material Separation
2
2
Device Operates Differently Than Expected
2
2
Activation Problem
1
1
Electrical Overstress
1
1
Battery Problem: Low Impedance
1
1
Misconnection
1
1
Material Deformation
1
1
Bent
1
1
Device Stops Intermittently
1
1
Overheating of Device
1
1
Disconnection
1
1
Patient-Device Incompatibility
1
1
Failure to Conduct
1
1
Connection Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
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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