TPLC - Total Product Life Cycle

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Device	implant, anti-gastroesophageal reflux
Product Code	LEI
Device Class	3

Premarket Approvals (PMA)
2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024	2025
3	5	3	4	4	1	6	2	1	0	6	2	1	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1041	1041
Device Appears to Trigger Rejection	601	601
Patient Device Interaction Problem	370	370
Detachment of Device or Device Component	235	235
Migration or Expulsion of Device	162	162
Appropriate Term/Code Not Available	110	110
Insufficient Information	59	59
Therapeutic or Diagnostic Output Failure	42	42
Unexpected Therapeutic Results	21	21
Material Erosion	18	18
Patient-Device Incompatibility	17	17
Device-Device Incompatibility	15	15
Nonstandard Device	13	13
Defective Component	9	9
Material Separation	8	8
Break	7	7
Use of Device Problem	6	6
Malposition of Device	4	4
Disconnection	4	4
Migration	3	3
Protective Measures Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Problem	2	2
Delivered as Unsterile Product	2	2
Device Dislodged or Dislocated	1	1
Fluid/Blood Leak	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Device Operates Differently Than Expected	1	1
Scratched Material	1	1
Contamination /Decontamination Problem	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Defective Device	1	1
Structural Problem	1	1
High Test Results	1	1
Obstruction of Flow	1	1
Physical Resistance/Sticking	1	1
Hole In Material	1	1
Device Slipped	1	1
Inadequacy of Device Shape and/or Size	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Dysphagia/ Odynophagia	1073	1073
No Code Available	459	459
Pyrosis/Heartburn	454	454
Insufficient Information	242	242
Pain	197	197
Vomiting	170	170
Hernia	122	122
Nausea	77	77
Pocket Erosion	74	74
Erosion	69	69
Abdominal Pain	56	56
Chest Pain	51	51
Cramp(s) /Muscle Spasm(s)	44	44
Abdominal Distention	41	41
Weight Changes	36	36
Inflammation	33	33
No Consequences Or Impact To Patient	25	25
No Information	21	21
Paresis	20	20
No Known Impact Or Consequence To Patient	18	18
Discomfort	16	16
Anxiety	13	13
Foreign Body In Patient	12	12
Muscle Spasm(s)	11	11
Not Applicable	10	10
Adhesion(s)	10	10
Scar Tissue	10	10
No Clinical Signs, Symptoms or Conditions	9	9
Pneumonia	9	9
Choking	9	9
Failure of Implant	8	8
Obstruction/Occlusion	8	8
Diarrhea	8	8
High Blood Pressure/ Hypertension	7	7
Headache	7	7
Burning Sensation	6	6
Regurgitation	6	6
Unspecified Infection	6	6
Speech Disorder	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Fatigue	5	5
Flatus	5	5
Dehydration	5	5
Complaint, Ill-Defined	5	5
Abscess	5	5
Perforation of Esophagus	4	4
Hypersensitivity/Allergic reaction	4	4
Autoimmune Disorder	4	4
Ulcer	4	4
Dyspnea	3	3

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