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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, autonomic nerve, implanted for epilepsy
Product CodeLYJ
Device Class 3

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

MDR Year MDR Reports MDR Events
2020 1688 1688
2021 1764 1764
2022 1584 1584
2023 1764 1764
2024 1525 1581
2025 352 352

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4664 4713
Fracture 1930 1937
High impedance 986 993
Low impedance 260 260
Premature Discharge of Battery 239 239
Naturally Worn 233 233
Device Contamination with Body Fluid 203 203
Electrical Shorting 122 122
Corroded 121 121
Inappropriate or Unexpected Reset 94 94
Physical Resistance/Sticking 92 92
False Alarm 88 88
Incomplete or Inadequate Connection 85 85
Insufficient Information 83 90
Failure to Deliver Energy 82 82
Premature End-of-Life Indicator 79 79
Failure to Interrogate 70 70
Output below Specifications 70 70
Energy Output Problem 65 65
Computer Software Problem 60 60
Detachment of Device or Device Component 59 59
Therapeutic or Diagnostic Output Failure 57 57
Mechanical Problem 40 40
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Material Twisted/Bent 34 34
Therapy Delivered to Incorrect Body Area 33 33
Device Contaminated During Manufacture or Shipping 33 33
Application Program Problem: Parameter Calculation Error 30 30
Defective Component 27 27
No Apparent Adverse Event 21 21
Electro-Static Discharge 19 19
Premature Elective Replacement Indicator 13 13
Migration 13 13
Communication or Transmission Problem 11 11
Battery Problem: High Impedance 10 10
Erratic or Intermittent Display 7 7
Over-Sensing 6 6
Protective Measures Problem 4 4
Break 3 3
Application Program Problem: Dose Calculation Error 3 3
Nonstandard Device 2 2
No Display/Image 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Scratched Material 1 1
Output Problem 1 1
Impedance Problem 1 1
Device-Device Incompatibility 1 1
Firing Problem 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2942 2949
Convulsion, Clonic 1689 1689
No Known Impact Or Consequence To Patient 706 706
Seizures 496 496
Post Operative Wound Infection 432 481
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 416 416
Implant Pain 275 275
Discomfort 240 240
Neck Pain 195 195
Paralysis 191 240
Unspecified Infection 172 172
Chest Pain 156 156
Pocket Erosion 139 139
No Code Available 135 135
Insufficient Information 120 120
Wound Dehiscence 109 109
Skin Infection 108 108
Dyspnea 105 105
Pain 105 105
Bradycardia 100 100
Apnea 97 97
Status Epilepticus 89 89
Dysphagia/ Odynophagia 81 81
Vomiting 71 71
Death 61 61
Arrhythmia 52 52
Paresis 52 101
Cough 51 51
Sleep Dysfunction 51 51
Unspecified Mental, Emotional or Behavioural Problem 50 50
Headache 49 49
Shock from Patient Lead(s) 41 41
Cramp(s) /Muscle Spasm(s) 38 38
Syncope/Fainting 37 37
Ambulation Difficulties 34 34
Hemorrhage/Bleeding 33 33
Impaired Healing 33 33
Asystole 32 32
Tissue Breakdown 32 32
Nerve Damage 32 32
Tachycardia 31 31
Ecchymosis 31 31
Nausea 30 30
Weight Changes 30 30
Unspecified Heart Problem 29 29
Depression 28 28
Fibrosis 27 27
Aspiration/Inhalation 27 27
Inflammation 27 27
Local Reaction 24 24

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
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