TPLC - Total Product Life Cycle

show TPLC since

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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1085	1085
Device Appears to Trigger Rejection	645	645
Patient Device Interaction Problem	416	416
Detachment of Device or Device Component	266	266
Migration or Expulsion of Device	177	177
Appropriate Term/Code Not Available	113	113
Insufficient Information	64	64
Therapeutic or Diagnostic Output Failure	42	42
Unexpected Therapeutic Results	21	21
Material Erosion	18	18
Device-Device Incompatibility	17	17
Patient-Device Incompatibility	17	17
Nonstandard Device	13	13
Defective Component	9	9
Material Separation	8	8
Break	7	7
Use of Device Problem	7	7
Migration	4	4
Malposition of Device	4	4
Disconnection	4	4
Protective Measures Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Delivered as Unsterile Product	2	2
Mechanical Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination /Decontamination Problem	1	1
Scratched Material	1	1
Difficult to Remove	1	1
Obstruction of Flow	1	1
Material Integrity Problem	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
High Test Results	1	1
Material Deformation	1	1
Defective Device	1	1
Unintended Movement	1	1
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Physical Resistance/Sticking	1	1
Device Operates Differently Than Expected	1	1
Device Dislodged or Dislocated	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	1122	1122
Pyrosis/Heartburn	482	482
No Code Available	459	459
Insufficient Information	295	295
Pain	209	209
Vomiting	180	180
Hernia	138	138
Pocket Erosion	83	83
Nausea	82	82
Erosion	69	69
Abdominal Pain	56	56
Chest Pain	56	56
Cramp(s) /Muscle Spasm(s)	49	49
Abdominal Distention	46	46
Weight Changes	41	41
Inflammation	37	37
No Consequences Or Impact To Patient	25	25
Paresis	22	22
No Information	21	21
Discomfort	19	19
No Known Impact Or Consequence To Patient	18	18
Anxiety	15	15
Choking	13	13
Foreign Body In Patient	12	12
Adhesion(s)	11	11
Muscle Spasm(s)	11	11
Not Applicable	10	10
Scar Tissue	10	10
Diarrhea	10	10
Pneumonia	10	10
Headache	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Obstruction/Occlusion	9	9
High Blood Pressure/ Hypertension	9	9
Failure of Implant	8	8
Unspecified Infection	8	8
Hemorrhage/Bleeding	7	7
Fatigue	7	7
Speech Disorder	6	6
Regurgitation	6	6
Abscess	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Burning Sensation	6	6
Dehydration	5	5
Flatus	5	5
Ulcer	5	5
Complaint, Ill-Defined	5	5
Hypersensitivity/Allergic reaction	4	4
Autoimmune Disorder	4	4
Pneumothorax	4	4

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