TPLC - Total Product Life Cycle

• Device: stimulator, autonomic nerve, implanted for epilepsy
• Product Code: LYJ
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
7	6	1	3	5	2

MDR Year	MDR Reports	MDR Events
2019	2432	2432
2020	1688	1688
2021	1764	1764
2022	1584	1584
2023	1764	1764
2024	1048	1104

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5481	5530
Fracture	2176	2183
High impedance	1236	1243
Low impedance	291	291
Device Contamination with Body Fluid	240	240
Premature End-of-Life Indicator	239	239
Premature Discharge of Battery	209	209
Naturally Worn	200	200
Corroded	171	171
Energy Output Problem	155	155
Computer Software Problem	142	142
Mechanical Problem	100	100
Electrical Shorting	93	93
False Alarm	88	88
Insufficient Information	86	93
Incorrect, Inadequate or Imprecise Result or Readings	86	86
Inappropriate or Unexpected Reset	82	82
Detachment of Device or Device Component	78	78
Incomplete or Inadequate Connection	71	71
Physical Resistance/Sticking	70	70
Failure to Interrogate	68	68
Device Contaminated During Manufacture or Shipping	67	67
Output below Specifications	62	62
Failure to Deliver Energy	61	61
Therapeutic or Diagnostic Output Failure	51	51
Material Twisted/Bent	29	29
Application Program Problem: Parameter Calculation Error	29	29
Therapy Delivered to Incorrect Body Area	24	24
Defective Component	22	22
No Apparent Adverse Event	21	21
Communication or Transmission Problem	20	20
Electro-Static Discharge	14	14
Appropriate Term/Code Not Available	12	12
Migration	9	9
Battery Problem: High Impedance	8	8
Over-Sensing	7	7
Premature Elective Replacement Indicator	7	7
Protective Measures Problem	5	5
Nonstandard Device	4	4
Output Problem	4	4
Erratic or Intermittent Display	3	3
No Display/Image	3	3
Break	3	3
Application Program Problem: Dose Calculation Error	2	2
Defective Device	2	2
Under-Sensing	2	2
Computer Operating System Problem	1	1
Impedance Problem	1	1
Battery Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2590	2597
No Known Impact Or Consequence To Patient	1709	1709
Convulsion, Clonic	1476	1476
Seizures	1069	1069
Post Operative Wound Infection	390	439
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	372	372
Unspecified Infection	367	367
No Code Available	367	367
Pain	269	269
Paralysis	236	285
Implant Pain	235	235
Neck Pain	233	233
Chest Pain	202	202
Discomfort	196	196
Death	144	144
Arrhythmia	130	130
Dyspnea	129	129
Wound Dehiscence	123	123
Pocket Erosion	119	119
Apnea	116	116
Insufficient Information	107	107
Dysphagia/ Odynophagia	104	104
Bradycardia	88	88
Vomiting	87	87
Tissue Breakdown	80	80
Skin Infection	80	80
Status Epilepticus	76	76
Paresis	61	110
Sleep Dysfunction	59	59
Headache	54	54
Muscle Spasm(s)	51	51
Unspecified Mental, Emotional or Behavioural Problem	47	47
Nerve Damage	46	46
No Information	44	44
Cough	43	43
Weight Changes	40	40
Impaired Healing	40	40
Ecchymosis	39	39
Shock from Patient Lead(s)	37	37
Depression	37	37
Nausea	36	36
Ambulation Difficulties	36	36
Cramp(s) /Muscle Spasm(s)	35	35
Syncope	34	34
Fibrosis	34	34
Syncope/Fainting	32	32
Hemorrhage/Bleeding	32	32
Cognitive Changes	31	31
Asystole	30	30
Edema	30	30

Recalls
Manufacturer		Recall Class	Date Posted
1	LivaNova USA Inc	II	Dec-04-2020
2	LivaNova USA Inc	II	Nov-17-2020
3	LivaNova USA Inc	II	Mar-24-2020
4	LivaNova USA Inc	II	Feb-10-2020
5	LivaNova USA Inc	II	Jan-27-2020
6	LivaNova USA Inc	I	Dec-20-2019
7	LivaNova USA Inc	II	Dec-10-2019
8	LivaNova USA Inc	II	Nov-07-2019
9	LivaNova USA, Inc.	II	Jan-28-2022