TPLC - Total Product Life Cycle

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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

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
Nonstandard Device	13	13
Device-Device Incompatibility	13	13
Defective Component	9	9
Material Separation	8	8
Break	7	7
Use of Device Problem	6	6
Malposition of Device	4	4
Improper or Incorrect Procedure or Method	4	4
Disconnection	4	4
Migration	3	3
Protective Measures Problem	3	3
Mechanical Problem	2	2
Device Operates Differently Than Expected	2	2
Hole In Material	1	1
Fluid/Blood Leak	1	1
Device Slipped	1	1
Physical Resistance/Sticking	1	1
Device Dislodged or Dislocated	1	1
Delivered as Unsterile Product	1	1
Device Damaged by Another Device	1	1
Structural Problem	1	1
High Test Results	1	1
Material Deformation	1	1
Obstruction of Flow	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Difficult to Remove	1	1
Scratched Material	1	1
Contamination /Decontamination Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Defective Device	1	1
Unintended Movement	1	1
Material Integrity Problem	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
Failure of Implant	8	8
Pneumonia	8	8
Obstruction/Occlusion	8	8
Adhesion(s)	8	8
Regurgitation	8	8
Scar Tissue	8	8
Burning Sensation	7	7
Complaint, Ill-Defined	7	7
No Clinical Signs, Symptoms or Conditions	7	7
High Blood Pressure/ Hypertension	7	7
Unspecified Infection	6	6
Headache	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Speech Disorder	6	6
Dehydration	5	5
Fatigue	5	5
Flatus	5	5
Perforation of Esophagus	4	4
Hypersensitivity/Allergic reaction	4	4
Abscess	4	4
Autoimmune Disorder	4	4
Pneumothorax	3	3
Blood Loss	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Torax Medical, Inc.	II	May-31-2018