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TPLC
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Device
intestinal stimulator
Product Code
LNQ
Device Class
Humanitarian Device Exemption
MDR Year
MDR Reports
MDR Events
2020
177
177
2021
188
188
2022
185
185
2023
165
165
2024
160
160
2025
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
261
261
Insufficient Information
230
230
Inappropriate/Inadequate Shock/Stimulation
131
131
Migration or Expulsion of Device
87
87
Battery Problem
69
69
High impedance
62
62
Break
44
44
Premature Discharge of Battery
38
38
Electromagnetic Compatibility Problem
37
37
Patient Device Interaction Problem
31
31
Impedance Problem
29
29
Unstable
22
22
Appropriate Term/Code Not Available
18
18
Failure to Deliver Energy
17
17
Energy Output Problem
17
17
Malposition of Device
14
14
Electromagnetic Interference
14
14
Entrapment of Device
13
13
Migration
12
12
Intermittent Continuity
10
10
Material Deformation
10
10
Communication or Transmission Problem
9
9
Failure to Interrogate
9
9
Positioning Problem
9
9
Pocket Stimulation
8
8
Connection Problem
8
8
Disconnection
7
7
Therapy Delivered to Incorrect Body Area
5
5
Overheating of Device
5
5
No Apparent Adverse Event
4
4
Environmental Compatibility Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Intermittent Shock/Stimulation
4
4
Patient-Device Incompatibility
4
4
Unintended Collision
4
4
Unintended Electrical Shock
4
4
Vibration
3
3
Data Problem
3
3
Material Puncture/Hole
3
3
Device Dislodged or Dislocated
3
3
Unexpected Therapeutic Results
2
2
Human-Device Interface Problem
2
2
Display or Visual Feedback Problem
2
2
Loose or Intermittent Connection
2
2
Low impedance
2
2
Device Contamination with Chemical or Other Material
2
2
Material Perforation
2
2
Use of Device Problem
2
2
Degraded
2
2
Unintended Movement
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
204
204
Electric Shock
165
165
Insufficient Information
154
154
Pain
141
141
Failure of Implant
98
98
Vomiting
93
93
Nausea
92
92
Unspecified Infection
80
80
No Known Impact Or Consequence To Patient
39
39
Discomfort
36
36
Abdominal Pain
30
30
Therapeutic Response, Decreased
26
26
Complaint, Ill-Defined
21
21
Therapeutic Effects, Unexpected
20
20
Erosion
20
20
Weight Changes
19
19
Malaise
19
19
Pocket Erosion
17
17
Internal Organ Perforation
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
16
16
Paresis
13
13
Undesired Nerve Stimulation
12
12
Seroma
11
11
Burning Sensation
10
10
Swelling/ Edema
9
9
Obstruction/Occlusion
9
9
Cramp(s) /Muscle Spasm(s)
9
9
Erythema
8
8
Scar Tissue
7
7
Sepsis
7
7
Abdominal Distention
7
7
Implant Pain
6
6
Constipation
6
6
Muscle Spasm(s)
6
6
Diarrhea
6
6
Foreign Body In Patient
6
6
Device Embedded In Tissue or Plaque
6
6
Fluid Discharge
5
5
Hypersensitivity/Allergic reaction
5
5
Foreign Body Reaction
5
5
Skin Infection
5
5
Anxiety
4
4
Shaking/Tremors
4
4
Dehydration
4
4
Twitching
4
4
Swelling
4
4
Fever
4
4
Impaired Healing
4
4
Post Operative Wound Infection
4
4
Wound Dehiscence
4
4
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