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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
2014
413
413
2015
300
300
2016
377
377
2017
438
438
2018
325
325
2019
258
258
2020
177
177
2021
188
188
2022
185
185
2023
165
165
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
752
752
Device Operates Differently Than Expected
554
554
Inappropriate/Inadequate Shock/Stimulation
422
422
Migration or Expulsion of Device
261
261
Insufficient Information
256
256
High impedance
197
197
Electromagnetic Compatibility Problem
158
158
Break
147
147
Battery Problem
133
133
Premature Discharge of Battery
107
107
Failure to Deliver Energy
99
99
Unstable
93
93
Low Battery
89
89
Impedance Problem
86
86
Electromagnetic Interference
70
70
Unintended Collision
70
70
Malposition of Device
64
64
Patient Device Interaction Problem
59
59
Energy Output Problem
53
53
Pocket Stimulation
44
44
Communication or Transmission Problem
41
41
Intermittent Continuity
40
40
Overheating of Device
39
39
Material Deformation
36
36
Failure to Interrogate
34
34
Positioning Problem
32
32
Therapy Delivered to Incorrect Body Area
29
29
Entrapment of Device
26
26
Device Or Device Fragments Location Unknown
26
26
Disconnection
25
25
Device Displays Incorrect Message
20
20
Connection Problem
15
15
Low impedance
15
15
Environmental Compatibility Problem
13
13
Human-Device Interface Problem
13
13
Appropriate Term/Code Not Available
12
12
Shipping Damage or Problem
11
11
Device Contamination with Chemical or Other Material
11
11
Degraded
10
10
Shelf Life Exceeded
10
10
Unexpected Therapeutic Results
9
9
Material Erosion
7
7
Energy Output To Patient Tissue Incorrect
7
7
Vibration
6
6
Noise, Audible
6
6
Electro-Static Discharge
5
5
Device Dislodged or Dislocated
5
5
Display or Visual Feedback Problem
5
5
No Device Output
5
5
Patient-Device Incompatibility
4
4
Improper or Incorrect Procedure or Method
4
4
Intermittent Shock/Stimulation
4
4
Data Problem
4
4
Unintended Electrical Shock
4
4
Loss of Data
3
3
Ambient Noise Problem
3
3
Material Twisted/Bent
3
3
Device Difficult to Program or Calibrate
3
3
Material Puncture/Hole
3
3
Unable to Obtain Readings
3
3
Difficult to Remove
3
3
Device Inoperable
2
2
Peeled/Delaminated
2
2
Improper Device Output
2
2
Compatibility Problem
2
2
Material Perforation
2
2
Unintended Movement
2
2
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Device Fell
1
1
Detachment of Device or Device Component
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Use of Device Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unauthorized Access to Computer System
1
1
Output Problem
1
1
Misassembled
1
1
Nonstandard Device
1
1
Failure to Read Input Signal
1
1
Inadequacy of Device Shape and/or Size
1
1
Corroded
1
1
Bent
1
1
Computer Software Problem
1
1
Loose or Intermittent Connection
1
1
Grounding Malfunction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
508
508
Pain
476
476
Vomiting
467
467
Nausea
442
442
Electric Shock
414
414
Complaint, Ill-Defined
401
401
Therapeutic Response, Decreased
391
391
Therapeutic Effects, Unexpected
323
323
No Clinical Signs, Symptoms or Conditions
182
182
Abdominal Pain
178
178
Unspecified Infection
178
178
Insufficient Information
152
152
Malaise
146
146
Discomfort
142
142
Paresis
138
138
Weight Changes
98
98
Undesired Nerve Stimulation
72
72
Erosion
68
68
No Code Available
64
64
Burning Sensation
63
63
Internal Organ Perforation
56
56
Constipation
54
54
Abdominal Distention
44
44
Obstruction/Occlusion
44
44
Seroma
41
41
Swelling
41
41
Diarrhea
40
40
Hernia
39
39
Muscle Spasm(s)
36
36
Pocket Erosion
35
35
Dehydration
29
29
Staphylococcus Aureus
25
25
Scar Tissue
24
24
Hemorrhage/Bleeding
24
24
Fever
22
22
Sepsis
21
21
Sleep Dysfunction
21
21
Abdominal Cramps
20
20
Test Result
20
20
Erythema
19
19
Bacterial Infection
19
19
Wound Dehiscence
19
19
Adhesion(s)
18
18
Urinary Tract Infection
18
18
Twiddlers Syndrome
18
18
Twitching
18
18
Foreign Body In Patient
18
18
Ambulation Difficulties
18
18
Device Embedded In Tissue or Plaque
17
17
Headache
17
17
Fluid Discharge
16
16
Hematoma
15
15
Device Overstimulation of Tissue
15
15
Weakness
14
14
Inflammation
13
13
Chest Pain
13
13
Cognitive Changes
13
13
Impaired Healing
13
13
Purulent Discharge
12
12
High Blood Pressure/ Hypertension
11
11
Pyrosis/Heartburn
11
11
Foreign Body Reaction
11
11
Cramp(s)
11
11
Hypersensitivity/Allergic reaction
10
10
Low Blood Pressure/ Hypotension
10
10
Dyspnea
10
10
Loss of consciousness
10
10
Disability
10
10
Cramp(s) /Muscle Spasm(s)
10
10
Swelling/ Edema
9
9
Post Operative Wound Infection
9
9
Depression
9
9
Anxiety
9
9
Distress
9
9
No Information
9
9
Dysphagia/ Odynophagia
9
9
Dizziness
9
9
Tachycardia
9
9
Seizures
8
8
Skin Erosion
8
8
Necrosis
8
8
Death
8
8
Abscess
8
8
Bruise/Contusion
8
8
Failure of Implant
8
8
Fall
8
8
Injury
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Lethargy
7
7
Eructate
7
7
Shock
7
7
Urinary Retention
7
7
Urinary Frequency
7
7
Ulcer
6
6
Tingling
6
6
Electrolyte Imbalance
6
6
Thrombosis
6
6
Rash
6
6
Muscle Weakness
6
6
Stroke/CVA
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Oct-29-2009
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