TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
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	560	560
Device Appears to Trigger Rejection	543	543
Patient Device Interaction Problem	329	329
Detachment of Device or Device Component	181	181
Migration or Expulsion of Device	147	147
Appropriate Term/Code Not Available	105	105
Therapeutic or Diagnostic Output Failure	42	42
Insufficient Information	41	41
Unexpected Therapeutic Results	20	20
Material Erosion	16	16
Device-Device Incompatibility	13	13
Patient-Device Incompatibility	13	13
Nonstandard Device	13	13
Material Separation	8	8
Break	6	6
Disconnection	4	4
Defective Component	4	4
Migration	3	3
Malposition of Device	3	3
Improper or Incorrect Procedure or Method	2	2
Use of Device Problem	2	2
Mechanical Problem	2	2
Inadequacy of Device Shape and/or Size	1	1
No Apparent Adverse Event	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
Obstruction of Flow	1	1
Contamination /Decontamination Problem	1	1
Scratched Material	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Physical Resistance/Sticking	1	1
Fluid/Blood Leak	1	1
Protective Measures Problem	1	1
Device Dislodged or Dislocated	1	1
High Test Results	1	1
Delivered as Unsterile Product	1	1
Material Deformation	1	1
Defective Device	1	1
Unintended Movement	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Dysphagia/ Odynophagia	761	761
No Code Available	404	404
Pyrosis/Heartburn	307	307
Insufficient Information	193	193
Pain	170	170
Vomiting	150	150
Hernia	106	106
Pocket Erosion	66	66
Nausea	66	66
Cramp(s) /Muscle Spasm(s)	41	41
Abdominal Distention	36	36
Chest Pain	35	35
Weight Changes	34	34
Inflammation	32	32
Erosion	30	30
No Consequences Or Impact To Patient	20	20
Paresis	19	19
Foreign Body In Patient	12	12
Anxiety	12	12
Muscle Spasm(s)	11	11
Discomfort	11	11
Not Applicable	10	10
Choking	9	9
Pneumonia	8	8
Adhesion(s)	8	8
Failure of Implant	8	8
Scar Tissue	8	8
Obstruction/Occlusion	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Diarrhea	7	7
Abdominal Pain	7	7
Speech Disorder	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
High Blood Pressure/ Hypertension	6	6
Headache	5	5
Dehydration	5	5
Unspecified Infection	5	5
Fatigue	4	4
Autoimmune Disorder	4	4
Hypersensitivity/Allergic reaction	4	4
Burning Sensation	4	4
Unspecified Tissue Injury	3	3
Abscess	3	3
Swelling/ Edema	3	3
Blood Loss	3	3
Hemorrhage/Bleeding	3	3
Dyspnea	3	3
Syncope/Fainting	3	3
Depression	2	2
Respiratory Failure	2	2