TPLC - Total Product Life Cycle

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Device	implant, intragastric for morbid obesity
Product Code	LTI
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
4	7	10	1	2	3	6	14	14	32	21	5	3	2	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1159	1159
Adverse Event Without Identified Device or Use Problem	868	868
Insufficient Information	851	851
Deflation Problem	652	652
Device Slipped	405	405
Patient-Device Incompatibility	236	236
Leak/Splash	195	195
Unintended Deflation	185	185
Migration or Expulsion of Device	160	160
Free or Unrestricted Flow	158	158
Inflation Problem	121	121
Air/Gas in Device	91	91
Migration	88	88
Material Erosion	87	87
Appropriate Term/Code Not Available	86	86
Use of Device Problem	61	61
Device Operates Differently Than Expected	57	57
Break	52	52
No Apparent Adverse Event	46	46
Detachment of Device or Device Component	41	41
Disconnection	31	31
Device Issue	24	24
Material Separation	23	23
Patient Device Interaction Problem	23	23
Obstruction of Flow	18	18
Fracture	18	18
Detachment Of Device Component	15	15
Malposition of Device	14	14
Device Dislodged or Dislocated	14	14
Improper or Incorrect Procedure or Method	13	13
Mechanical Problem	13	13
Inadequacy of Device Shape and/or Size	12	12
Difficult to Remove	12	12
Unintended Movement	12	12
Extrusion	11	11
Material Integrity Problem	10	10
Therapeutic or Diagnostic Output Failure	8	8
Defective Device	8	8
Material Rupture	7	7
Burst Container or Vessel	7	7
Output Problem	7	7
Device Inoperable	7	7
Filling Problem	7	7
Nonstandard Device	6	6
Kinked	6	6
Entrapment of Device	6	6
Loose or Intermittent Connection	6	6
Material Twisted/Bent	6	6
Hole In Material	6	6
Infusion or Flow Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	1090	1090
Vomiting	1031	1031
Pain	668	669
Insufficient Information	557	557
No Clinical Signs, Symptoms or Conditions	469	469
Abdominal Pain	444	444
Nausea	442	443
Patient Problem/Medical Problem	347	347
Erosion	316	317
Dysphagia/ Odynophagia	187	188
Regurgitation	186	186
Obstruction/Occlusion	182	183
Unspecified Infection	128	128
No Code Available	128	128
No Known Impact Or Consequence To Patient	118	118
Dehydration	114	114
Pyrosis/Heartburn	111	111
Hernia	110	110
Inflammation	108	108
Weight Changes	97	97
No Information	93	93
Ulcer	73	73
No Consequences Or Impact To Patient	64	64
Malaise	63	64
Perforation	50	50
Internal Organ Perforation	49	49
Hemorrhage/Bleeding	46	46
Adhesion(s)	42	43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	39	39
Fever	38	38
Scar Tissue	38	38
Discomfort	36	36
Constipation	35	35
Complaint, Ill-Defined	32	32
Death	32	32
Diarrhea	32	32
Dyspnea	31	31
Sepsis	31	31
Abdominal Cramps	30	30
Abdominal Distention	30	30
Aspiration/Inhalation	30	30
Irritation	29	29
Chest Pain	28	28
Perforation of Esophagus	27	27
Foreign Body In Patient	26	26
Gastritis	25	25
Other (for use when an appropriate patient code cannot be identified)	24	24
Blood Loss	24	24
Pneumonia	24	24
Necrosis	23	23