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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 0

MDR Year MDR Reports MDR Events
2020 1688 1688
2021 1764 1764
2022 1584 1584
2023 1764 1764
2024 1525 1581
2025 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4527 4576
Fracture 1872 1879
High impedance 961 968
Low impedance 249 249
Naturally Worn 222 222
Premature Discharge of Battery 222 222
Device Contamination with Body Fluid 191 191
Corroded 115 115
Electrical Shorting 110 110
Inappropriate or Unexpected Reset 90 90
Physical Resistance/Sticking 88 88
False Alarm 88 88
Failure to Deliver Energy 80 80
Insufficient Information 79 86
Incomplete or Inadequate Connection 79 79
Premature End-of-Life Indicator 79 79
Output below Specifications 69 69
Failure to Interrogate 68 68
Energy Output Problem 65 65
Computer Software Problem 60 60
Detachment of Device or Device Component 59 59
Therapeutic or Diagnostic Output Failure 53 53
Mechanical Problem 40 40
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Device Contaminated During Manufacture or Shipping 33 33
Material Twisted/Bent 31 31
Therapy Delivered to Incorrect Body Area 31 31
Application Program Problem: Parameter Calculation Error 30 30
Defective Component 27 27
No Apparent Adverse Event 21 21
Electro-Static Discharge 16 16
Premature Elective Replacement Indicator 12 12
Communication or Transmission Problem 11 11
Migration 10 10
Battery Problem: High Impedance 10 10
Erratic or Intermittent Display 6 6
Over-Sensing 6 6
Protective Measures Problem 4 4
Break 3 3
Application Program Problem: Dose Calculation Error 3 3
Nonstandard Device 2 2
Defective Device 2 2
No Display/Image 2 2
Appropriate Term/Code Not Available 2 2
Device-Device Incompatibility 1 1
Scratched Material 1 1
Computer Operating System Problem 1 1
Failure to Deliver Shock/Stimulation 1 1
Unintended Electrical Shock 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2826 2833
Convulsion, Clonic 1617 1617
No Known Impact Or Consequence To Patient 706 706
Seizures 496 496
Post Operative Wound Infection 424 473
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 407 407
Implant Pain 265 265
Discomfort 230 230
Neck Pain 194 194
Paralysis 185 234
Unspecified Infection 172 172
Chest Pain 155 155
Pocket Erosion 136 136
No Code Available 135 135
Insufficient Information 118 118
Wound Dehiscence 107 107
Pain 105 105
Dyspnea 103 103
Skin Infection 101 101
Apnea 96 96
Bradycardia 95 95
Status Epilepticus 83 83
Dysphagia/ Odynophagia 80 80
Vomiting 69 69
Death 61 61
Arrhythmia 52 52
Sleep Dysfunction 51 51
Paresis 50 99
Unspecified Mental, Emotional or Behavioural Problem 50 50
Cough 50 50
Headache 48 48
Shock from Patient Lead(s) 41 41
Cramp(s) /Muscle Spasm(s) 38 38
Syncope/Fainting 35 35
Ambulation Difficulties 34 34
Impaired Healing 33 33
Hemorrhage/Bleeding 32 32
Tissue Breakdown 32 32
Nerve Damage 32 32
Ecchymosis 31 31
Tachycardia 31 31
Asystole 31 31
Weight Changes 30 30
Nausea 30 30
Unspecified Heart Problem 29 29
Depression 27 27
Aspiration/Inhalation 26 26
Fibrosis 26 26
Inflammation 26 26
Unspecified Respiratory Problem 23 23

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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