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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)
2021 2022 2023 2024 2025 2026
1 3 5 3 6 1

MDR Year MDR Reports MDR Events
2021 1764 1765
2022 1584 1584
2023 1764 1764
2024 1524 1580
2025 1455 1455
2026 523 523

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4608 4657
Fracture 1934 1941
High impedance 1014 1021
Premature Discharge of Battery 292 292
Naturally Worn 287 287
Low impedance 268 268
Device Contamination with Body Fluid 209 209
Electrical Shorting 167 167
Incomplete or Inadequate Connection 132 132
Physical Resistance/Sticking 120 120
Corroded 118 118
Inappropriate or Unexpected Reset 115 115
Failure to Deliver Energy 111 111
Insufficient Information 102 109
Output below Specifications 86 86
False Alarm 86 86
Failure to Interrogate 75 75
Therapeutic or Diagnostic Output Failure 65 65
Detachment of Device or Device Component 50 50
Material Twisted/Bent 47 47
Therapy Delivered to Incorrect Body Area 37 37
Defective Component 33 33
Electro-Static Discharge 31 31
Application Program Problem: Parameter Calculation Error 30 30
Device Contaminated During Manufacture or Shipping 29 29
No Apparent Adverse Event 25 25
Premature Elective Replacement Indicator 18 18
Migration 17 17
Battery Problem: High Impedance 12 12
Erratic or Intermittent Display 11 11
Premature End-of-Life Indicator 9 9
Mechanical Problem 6 6
Energy Output Problem 6 6
Computer Software Problem 5 5
Communication or Transmission Problem 4 4
Appropriate Term/Code Not Available 4 4
Application Program Problem: Dose Calculation Error 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Break 2 2
Connection Problem 2 2
Impedance Problem 2 2
Protective Measures Problem 2 2
Output Problem 1 1
Material Protrusion/Extrusion 1 1
Failure to Shut Off 1 1
Device-Device Incompatibility 1 1
Firing Problem 1 1
Unintended Electrical Shock 1 2
Unexpected Shutdown 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 3662 3669
Convulsion, Clonic 2103 2103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 518 519
Post Operative Wound Infection 472 521
Implant Pain 335 335
Discomfort 277 277
Paralysis 178 228
Neck Pain 177 177
Pocket Erosion 176 176
Insufficient Information 148 148
Skin Infection 145 145
Bradycardia 118 118
Chest Pain 116 116
Wound Dehiscence 112 112
Status Epilepticus 112 112
Dyspnea 90 90
Apnea 87 87
Vomiting 71 71
Dysphagia/ Odynophagia 64 64
No Known Impact Or Consequence To Patient 64 64
Unspecified Mental, Emotional or Behavioural Problem 60 60
Seizures 58 58
Cough 56 56
Paresis 53 102
Syncope/Fainting 52 52
Cramp(s) /Muscle Spasm(s) 51 51
Shock from Patient Lead(s) 50 50
Headache 49 49
Sleep Dysfunction 44 44
Asystole 37 37
Ambulation Difficulties 36 36
Unspecified Heart Problem 36 36
Tachycardia 36 36
Impaired Healing 33 33
Hemorrhage/Bleeding 31 31
Fibrosis 29 29
Nausea 29 29
Ecchymosis 29 29
Nerve Damage 29 29
Inflammation 26 26
Aspiration/Inhalation 25 25
Decreased Appetite 24 24
Unspecified Respiratory Problem 23 23
Depression 22 22
Cardiac Arrest 21 21
Extreme Exhaustion 21 21
Hypoesthesia 20 20
Hypoxia 19 19
Scar Tissue 19 19
Pneumonia 19 19

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova USA, Inc. II Jan-31-2025
2 LivaNova USA, Inc. II Jan-30-2025
3 LivaNova USA, Inc. II Jan-28-2022
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