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	618	618
Adverse Event Without Identified Device or Use Problem	475	475
Patient Device Interaction Problem	312	312
Detachment of Device or Device Component	261	261
Migration or Expulsion of Device	147	147
Appropriate Term/Code Not Available	62	62
Insufficient Information	50	50
Device-Device Incompatibility	17	17
Break	1	1
Mechanical Problem	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Delivered as Unsterile Product	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	606	606
Pyrosis/Heartburn	309	309
Insufficient Information	301	301
Pain	130	130
Vomiting	128	128
Hernia	109	109
Pocket Erosion	81	81
Cramp(s) /Muscle Spasm(s)	46	46
Nausea	44	44
Weight Changes	39	39
Chest Pain	28	28
Inflammation	27	27
Abdominal Distention	26	26
Paresis	22	22
Discomfort	16	16
Choking	13	13
Anxiety	10	10
Pneumonia	8	8
No Clinical Signs, Symptoms or Conditions	8	8
Adhesion(s)	8	8
Unspecified Infection	7	7
Scar Tissue	7	7
Diarrhea	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
High Blood Pressure/ Hypertension	6	6
Speech Disorder	6	6
Hemorrhage/Bleeding	5	5
Abscess	5	5
Dehydration	5	5
Fatigue	4	4
Obstruction/Occlusion	4	4
Autoimmune Disorder	4	4
Headache	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Syncope/Fainting	3	3
Dizziness	3	3
Failure of Implant	3	3
Arrhythmia	3	3
Hypersensitivity/Allergic reaction	3	3
Burning Sensation	2	2
Foreign Body In Patient	2	2
Fever	2	2
Respiratory Failure	2	2
Nerve Damage	2	2
Asthma	2	2
Urinary Retention	2	2
Respiratory Tract Infection	2	2
Ulcer	2	2
Necrosis	2	2