TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
6	1	3	5	3	4

MDR Year	MDR Reports	MDR Events
2020	1688	1689
2021	1764	1765
2022	1584	1584
2023	1764	1764
2024	1524	1580
2025	1209	1209

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5119	5168
Fracture	2111	2118
High impedance	1085	1092
Low impedance	294	294
Premature Discharge of Battery	272	272
Naturally Worn	268	268
Device Contamination with Body Fluid	230	230
Electrical Shorting	153	153
Corroded	138	138
Physical Resistance/Sticking	112	112
Inappropriate or Unexpected Reset	109	109
Incomplete or Inadequate Connection	107	107
Failure to Deliver Energy	102	102
Insufficient Information	96	103
False Alarm	88	88
Output below Specifications	80	80
Premature End-of-Life Indicator	79	79
Failure to Interrogate	76	76
Energy Output Problem	65	65
Computer Software Problem	61	61
Detachment of Device or Device Component	60	60
Therapeutic or Diagnostic Output Failure	59	59
Mechanical Problem	40	40
Material Twisted/Bent	39	39
Incorrect, Inadequate or Imprecise Result or Readings	37	37
Therapy Delivered to Incorrect Body Area	35	35
Device Contaminated During Manufacture or Shipping	34	34
Defective Component	31	31
Application Program Problem: Parameter Calculation Error	31	31
Electro-Static Discharge	23	23
No Apparent Adverse Event	23	23
Premature Elective Replacement Indicator	19	19
Migration	16	16
Battery Problem: High Impedance	13	13
Communication or Transmission Problem	11	11
Erratic or Intermittent Display	10	10
Over-Sensing	6	6
Protective Measures Problem	4	4
Break	3	3
Application Program Problem: Dose Calculation Error	3	3
No Display/Image	2	2
Nonstandard Device	2	3
Appropriate Term/Code Not Available	2	2
Output Problem	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Defective Device	2	2
Unintended Electrical Shock	1	2
Computer Operating System Problem	1	1
Patient-Device Incompatibility	1	1
Fail-Safe Did Not Operate	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3333	3340
Convulsion, Clonic	1914	1915
No Known Impact Or Consequence To Patient	706	706
Seizures	496	497
Post Operative Wound Infection	462	511
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	458	459
Implant Pain	305	305
Discomfort	257	257
Neck Pain	207	207
Paralysis	207	257
Unspecified Infection	172	172
Pocket Erosion	160	160
Chest Pain	157	157
No Code Available	135	135
Insufficient Information	133	133
Skin Infection	128	128
Wound Dehiscence	123	123
Dyspnea	111	111
Bradycardia	109	109
Status Epilepticus	107	107
Pain	106	106
Apnea	101	101
Dysphagia/ Odynophagia	85	85
Vomiting	77	77
Death	61	61
Unspecified Mental, Emotional or Behavioural Problem	58	58
Paresis	55	104
Sleep Dysfunction	53	53
Arrhythmia	53	53
Headache	53	53
Cough	52	52
Shock from Patient Lead(s)	47	47
Syncope/Fainting	44	44
Cramp(s) /Muscle Spasm(s)	44	44
Ambulation Difficulties	39	39
Nerve Damage	39	39
Impaired Healing	35	35
Asystole	34	34
Ecchymosis	34	34
Tachycardia	34	34
Unspecified Heart Problem	34	34
Hemorrhage/Bleeding	34	34
Tissue Breakdown	32	32
Nausea	31	31
Depression	31	31
Weight Changes	30	31
Inflammation	29	29
Fibrosis	29	29
Aspiration/Inhalation	28	28
Decreased Appetite	25	25

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.	II	Jan-31-2025
7	LivaNova USA, Inc.	II	Jan-30-2025
8	LivaNova USA, Inc.	II	Jan-28-2022