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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
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
754
754
Device Operates Differently Than Expected
554
554
Inappropriate/Inadequate Shock/Stimulation
427
427
Insufficient Information
263
263
Migration or Expulsion of Device
261
261
High impedance
197
197
Electromagnetic Compatibility Problem
158
158
Break
147
147
Battery Problem
134
134
Premature Discharge of Battery
107
107
Failure to Deliver Energy
99
99
Unstable
93
93
Low Battery
89
89
Impedance Problem
88
88
Electromagnetic Interference
70
70
Unintended Collision
70
70
Malposition of Device
64
64
Patient Device Interaction Problem
59
59
Energy Output Problem
54
54
Pocket Stimulation
44
44
Communication or Transmission Problem
41
41
Intermittent Continuity
40
40
Overheating of Device
39
39
Material Deformation
37
37
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
Appropriate Term/Code Not Available
24
24
Device Displays Incorrect Message
20
20
Low impedance
15
15
Connection Problem
15
15
Environmental Compatibility Problem
13
13
Human-Device Interface Problem
13
13
Device Contamination with Chemical or Other Material
11
11
Shipping Damage or Problem
11
11
Degraded
10
10
Shelf Life Exceeded
10
10
Unexpected Therapeutic Results
9
9
Material Erosion
8
8
Energy Output To Patient Tissue Incorrect
7
7
Vibration
6
6
Noise, Audible
6
6
Electro-Static Discharge
5
5
Patient-Device Incompatibility
5
5
Device Dislodged or Dislocated
5
5
Display or Visual Feedback Problem
5
5
No Device Output
5
5
Intermittent Shock/Stimulation
4
4
Improper or Incorrect Procedure or Method
4
4
Unintended Electrical Shock
4
4
Data Problem
4
4
Material Twisted/Bent
3
3
Migration
3
3
Ambient Noise Problem
3
3
Loss of Data
3
3
Device Difficult to Program or Calibrate
3
3
Material Puncture/Hole
3
3
Difficult to Remove
3
3
Unable to Obtain Readings
3
3
Peeled/Delaminated
2
2
Improper Device Output
2
2
Compatibility Problem
2
2
Material Perforation
2
2
Device Inoperable
2
2
Use of Device Problem
2
2
Unintended Movement
2
2
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Device Fell
1
1
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unauthorized Access to Computer System
1
1
Defective Component
1
1
Microbial Contamination of Device
1
1
Component Missing
1
1
Battery Problem: Low Impedance
1
1
Detachment of Device or Device Component
1
1
Biocompatibility
1
1
Misassembled
1
1
Nonstandard Device
1
1
Device Appears to Trigger Rejection
1
1
Defibrillation/Stimulation Problem
1
1
Failure to Read Input Signal
1
1
Inadequacy of Device Shape and/or Size
1
1
Corroded
1
1
Failure to Deliver Shock/Stimulation
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
477
477
Vomiting
468
468
Nausea
443
443
Electric Shock
421
421
Complaint, Ill-Defined
401
401
Therapeutic Response, Decreased
391
391
Therapeutic Effects, Unexpected
323
323
No Clinical Signs, Symptoms or Conditions
186
186
Abdominal Pain
178
178
Unspecified Infection
178
178
Insufficient Information
156
156
Malaise
146
146
Discomfort
143
143
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
Failure of Implant
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
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
Swelling/ Edema
10
10
Cramp(s) /Muscle Spasm(s)
10
10
Loss of consciousness
10
10
Disability
10
10
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
Fall
8
8
Injury
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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