TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	6	2	1	1	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Appears to Trigger Rejection	637	637
Adverse Event Without Identified Device or Use Problem	489	489
Patient Device Interaction Problem	331	331
Detachment of Device or Device Component	285	285
Migration or Expulsion of Device	151	151
Appropriate Term/Code Not Available	62	62
Insufficient Information	54	54
Device-Device Incompatibility	18	18
Break	2	2
Delivered as Unsterile Product	2	2
Mechanical Problem	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Dysphagia/ Odynophagia	625	625
Insufficient Information	327	327
Pyrosis/Heartburn	320	320
Pain	135	135
Vomiting	131	131
Hernia	116	116
Pocket Erosion	83	83
Cramp(s) /Muscle Spasm(s)	47	47
Nausea	45	45
Weight Changes	40	40
Chest Pain	28	28
Inflammation	28	28
Abdominal Distention	26	26
Paresis	22	22
Discomfort	17	17
Choking	13	13
Scar Tissue	10	10
Anxiety	10	10
Adhesion(s)	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Pneumonia	8	8
Diarrhea	7	7
High Blood Pressure/ Hypertension	7	7
Unspecified Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Speech Disorder	6	6
Abscess	5	5
Dehydration	5	5
Obstruction/Occlusion	5	5
Autoimmune Disorder	5	5
Hemorrhage/Bleeding	5	5
Fatigue	4	4
Hypersensitivity/Allergic reaction	4	4
Headache	4	4
Syncope/Fainting	3	3
Dyspnea	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Arrhythmia	3	3
Burning Sensation	3	3
Failure of Implant	3	3
Dizziness	3	3
Fever	2	2
Foreign Body In Patient	2	2
Breast Cancer	2	2
Nerve Damage	2	2
Urinary Retention	2	2
Respiratory Tract Infection	2	2
Ulcer	2	2
Apnea	2	2