TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2019	280	280
2020	193	193
2021	263	263
2022	250	250
2023	246	246
2024	49	49

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	529	529
Device Appears to Trigger Rejection	508	508
Patient Device Interaction Problem	305	305
Detachment of Device or Device Component	163	163
Migration or Expulsion of Device	142	142
Appropriate Term/Code Not Available	105	105
Therapeutic or Diagnostic Output Failure	42	42
Insufficient Information	36	36
Unexpected Therapeutic Results	20	20
Material Erosion	16	16
Nonstandard Device	13	13
Patient-Device Incompatibility	13	13
Device-Device Incompatibility	12	12
Material Separation	8	8
Break	6	6
Disconnection	4	4
Defective Component	4	4
Malposition of Device	3	3
Migration	3	3
Mechanical Problem	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Obstruction of Flow	1	1
High Test Results	1	1
Structural Problem	1	1
Defective Device	1	1
Fluid/Blood Leak	1	1
Delivered as Unsterile Product	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination /Decontamination Problem	1	1
Device Dislodged or Dislocated	1	1
Material Deformation	1	1
Device Damaged by Another Device	1	1
Physical Resistance/Sticking	1	1
Unintended Movement	1	1
No Apparent Adverse Event	1	1
Protective Measures Problem	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Dysphagia/ Odynophagia	725	725
No Code Available	404	404
Pyrosis/Heartburn	289	289
Insufficient Information	175	175
Pain	163	163
Vomiting	141	141
Hernia	99	99
Nausea	62	62
Pocket Erosion	62	62
Abdominal Distention	36	36
Cramp(s) /Muscle Spasm(s)	34	34
Chest Pain	34	34
Weight Changes	31	31
Erosion	30	30
Inflammation	28	28
No Consequences Or Impact To Patient	20	20
Paresis	16	16
Anxiety	12	12
Foreign Body In Patient	12	12
Muscle Spasm(s)	11	11
Not Applicable	10	10
Discomfort	9	9
Choking	9	9
Obstruction/Occlusion	8	8
Failure of Implant	8	8
Adhesion(s)	8	8
Scar Tissue	7	7
No Clinical Signs, Symptoms or Conditions	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Pneumonia	6	6
Abdominal Pain	6	6
High Blood Pressure/ Hypertension	6	6
Diarrhea	6	6
Dehydration	4	4
Fatigue	4	4
Headache	4	4
Hypersensitivity/Allergic reaction	4	4
Autoimmune Disorder	4	4
Burning Sensation	4	4
Speech Disorder	4	4
Unspecified Tissue Injury	3	3
Syncope/Fainting	3	3
Blood Loss	3	3
Abscess	3	3
Hemorrhage/Bleeding	3	3
Dyspnea	3	3
Flatus	2	2
Unspecified Infection	2	2
Apnea	2	2
Arrhythmia	2	2
Asthma	2	2
Breast Cancer	2	2
Cardiac Arrest	2	2
Dizziness	2	2
Respiratory Failure	2	2
Depression	2	2
Perforation of Esophagus	2	2
Sepsis	2	2
Swelling	2	2
Urinary Retention	2	2
Necrosis	2	2
Nerve Damage	2	2
Neurological Deficit/Dysfunction	2	2
Swelling/ Edema	2	2
Bowel Perforation	1	1
No Known Impact Or Consequence To Patient	1	1
Alteration in Body Temperature	1	1
Decreased Appetite	1	1
Paresthesia	1	1
Pericarditis	1	1
Mitral Valve Insufficiency/ Regurgitation	1	1
Unspecified Respiratory Problem	1	1
Neuropathy	1	1
Muscular Rigidity	1	1
Myocardial Infarction	1	1
Pleural Effusion	1	1
Urinary Tract Infection	1	1
Pneumothorax	1	1
Rash	1	1
Numbness	1	1
Electric Shock	1	1
Neck Pain	1	1
Scarring	1	1
Scleroderma	1	1
Peritonitis	1	1
Stenosis	1	1
Ulcer	1	1
Death	1	1
Autoimmune Reaction	1	1
Bacterial Infection	1	1
Bruise/Contusion	1	1
Pulmonary Embolism	1	1
Arthritis	1	1
Adult Respiratory Distress Syndrome	1	1
Itching Sensation	1	1
Hypoxia	1	1