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TPLC
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show TPLC since
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Device
implant, anti-gastroesophageal reflux
Product Code
LEI
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
3
5
3
4
4
1
6
2
1
0
6
2
1
MDR Year
MDR Reports
MDR Events
2014
42
42
2015
57
57
2016
92
92
2017
133
133
2018
202
202
2019
280
280
2020
193
193
2021
263
263
2022
250
250
2023
246
246
2024
118
118
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1024
1024
Device Appears to Trigger Rejection
549
549
Patient Device Interaction Problem
329
329
Detachment of Device or Device Component
186
186
Migration or Expulsion of Device
148
148
Appropriate Term/Code Not Available
111
111
Insufficient Information
67
67
Therapeutic or Diagnostic Output Failure
42
42
Unexpected Therapeutic Results
21
21
Material Erosion
18
18
Patient-Device Incompatibility
17
17
Device-Device Incompatibility
13
13
Nonstandard Device
13
13
Defective Component
9
9
Material Separation
8
8
Break
7
7
Use of Device Problem
6
6
Disconnection
4
4
Improper or Incorrect Procedure or Method
4
4
Malposition of Device
4
4
Protective Measures Problem
3
3
Migration
3
3
Device Operates Differently Than Expected
2
2
Mechanical Problem
2
2
Obstruction of Flow
1
1
Scratched Material
1
1
Structural Problem
1
1
Device Damaged by Another Device
1
1
Delivered as Unsterile Product
1
1
High Test Results
1
1
Material Deformation
1
1
Contamination /Decontamination Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Inadequacy of Device Shape and/or Size
1
1
No Apparent Adverse Event
1
1
Difficult to Remove
1
1
Device Dislodged or Dislocated
1
1
Material Integrity Problem
1
1
Defective Device
1
1
Unintended Movement
1
1
Physical Resistance/Sticking
1
1
Device Slipped
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Dysphagia/ Odynophagia
1043
1043
No Code Available
460
460
Pyrosis/Heartburn
422
422
Insufficient Information
193
193
Pain
191
191
Vomiting
163
163
Hernia
114
114
Nausea
72
72
Erosion
69
69
Pocket Erosion
67
67
Abdominal Pain
60
60
Chest Pain
48
48
Cramp(s) /Muscle Spasm(s)
41
41
Abdominal Distention
38
38
Weight Changes
36
36
Inflammation
32
32
No Consequences Or Impact To Patient
25
25
No Information
23
23
No Known Impact Or Consequence To Patient
19
19
Paresis
19
19
Foreign Body In Patient
13
13
Anxiety
12
12
Muscle Spasm(s)
11
11
Discomfort
11
11
Not Applicable
10
10
Choking
9
9
Diarrhea
8
8
Regurgitation
8
8
Failure of Implant
8
8
Scar Tissue
8
8
Pneumonia
8
8
Obstruction/Occlusion
8
8
Adhesion(s)
8
8
High Blood Pressure/ Hypertension
7
7
Complaint, Ill-Defined
7
7
Burning Sensation
7
7
No Clinical Signs, Symptoms or Conditions
7
7
Speech Disorder
6
6
Headache
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Unspecified Infection
6
6
Dehydration
5
5
Fatigue
5
5
Flatus
5
5
Abscess
4
4
Perforation of Esophagus
4
4
Autoimmune Disorder
4
4
Hypersensitivity/Allergic reaction
4
4
Blood Loss
3
3
Swelling/ Edema
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Torax Medical, Inc.
II
May-31-2018
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