Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
intestinal stimulator
Product Code
LNQ
Device Class
Humanitarian Device Exemption
MDR Year
MDR Reports
MDR Events
2018
325
325
2019
258
258
2020
177
177
2021
188
188
2022
185
185
2023
52
52
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
312
312
Insufficient Information
226
226
Inappropriate/Inadequate Shock/Stimulation
198
198
Migration or Expulsion of Device
138
138
Battery Problem
95
95
High impedance
85
85
Electromagnetic Compatibility Problem
68
68
Device Operates Differently Than Expected
65
65
Break
61
61
Premature Discharge of Battery
50
50
Energy Output Problem
50
50
Impedance Problem
48
48
Unstable
46
46
Failure to Deliver Energy
39
39
Patient Device Interaction Problem
39
39
Electromagnetic Interference
25
25
Malposition of Device
22
22
Intermittent Continuity
20
20
Unintended Collision
20
20
Entrapment of Device
18
18
Material Deformation
18
18
Positioning Problem
16
16
Low Battery
16
16
Overheating of Device
15
15
Therapy Delivered to Incorrect Body Area
12
12
Pocket Stimulation
11
11
Communication or Transmission Problem
11
11
Connection Problem
10
10
Failure to Interrogate
10
10
Disconnection
10
10
Environmental Compatibility Problem
7
7
Appropriate Term/Code Not Available
7
7
Human-Device Interface Problem
6
6
Degraded
6
6
Low impedance
5
5
Device Displays Incorrect Message
5
5
Noise, Audible
4
4
Shipping Damage or Problem
4
4
Vibration
3
3
Improper or Incorrect Procedure or Method
3
3
Unexpected Therapeutic Results
3
3
Data Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Device Dislodged or Dislocated
3
3
Difficult to Remove
2
2
Peeled/Delaminated
2
2
Device Or Device Fragments Location Unknown
2
2
Display or Visual Feedback Problem
2
2
No Device Output
1
1
Corroded
1
1
Material Erosion
1
1
Grounding Malfunction
1
1
Electro-Static Discharge
1
1
Patient-Device Incompatibility
1
1
Ambient Noise Problem
1
1
Detachment of Device or Device Component
1
1
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
228
228
No Known Impact Or Consequence To Patient
197
197
Electric Shock
196
196
Vomiting
184
184
Nausea
166
166
No Clinical Signs, Symptoms or Conditions
151
151
Insufficient Information
124
124
Complaint, Ill-Defined
117
117
Therapeutic Response, Decreased
99
99
Therapeutic Effects, Unexpected
97
97
Unspecified Infection
84
84
Abdominal Pain
60
60
Malaise
57
57
Paresis
54
54
Discomfort
52
52
Erosion
37
37
Weight Changes
31
31
Burning Sensation
25
25
Internal Organ Perforation
23
23
Undesired Nerve Stimulation
21
21
Seroma
20
20
No Code Available
20
20
Constipation
19
19
Pocket Erosion
18
18
Diarrhea
14
14
Obstruction/Occlusion
14
14
Swelling
13
13
Foreign Body In Patient
13
13
Abdominal Distention
12
12
Scar Tissue
12
12
Muscle Spasm(s)
12
12
Sepsis
10
10
Fever
10
10
Bacterial Infection
9
9
Swelling/ Edema
9
9
Cramp(s) /Muscle Spasm(s)
9
9
Hernia
9
9
Twitching
8
8
Wound Dehiscence
8
8
Erythema
8
8
Dehydration
7
7
Sleep Dysfunction
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Fluid Discharge
6
6
Device Embedded In Tissue or Plaque
6
6
Ambulation Difficulties
6
6
Dysphagia/ Odynophagia
6
6
Hemorrhage/Bleeding
6
6
Inflammation
5
5
Headache
5
5
Foreign Body Reaction
5
5
Abscess
5
5
Bruise/Contusion
5
5
Staphylococcus Aureus
5
5
Hematoma
5
5
Cognitive Changes
5
5
Loss of consciousness
5
5
Impaired Healing
5
5
Anxiety
5
5
Shaking/Tremors
4
4
Failure of Implant
4
4
Rash
4
4
Urinary Tract Infection
4
4
Adhesion(s)
4
4
Dyspnea
4
4
Eructate
4
4
Purulent Discharge
3
3
Cellulitis
3
3
Irritation
3
3
Hypersensitivity/Allergic reaction
3
3
Hypoglycemia
3
3
Device Overstimulation of Tissue
3
3
Pneumonia
3
3
Tissue Breakdown
3
3
Test Result
3
3
Twiddlers Syndrome
3
3
Ulcer
3
3
Urinary Frequency
3
3
Injury
3
3
Abdominal Cramps
3
3
Post Operative Wound Infection
3
3
Distress
2
2
Cramp(s)
2
2
Viral Infection
2
2
Shock from Patient Lead(s)
2
2
Cancer
2
2
Incontinence
2
2
Twiddlers Syndrome
2
2
Urinary Retention
2
2
Pulmonary Edema
2
2
Seizures
2
2
Low Blood Pressure/ Hypotension
2
2
Hyperglycemia
2
2
Pyrosis/Heartburn
2
2
Chest Pain
2
2
Death
1
1
Calcium Deposits/Calcification
1
1
Edema
1
1
Emotional Changes
1
1
Feeding Problem
1
1
-
-