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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 0

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4293 4342
Fracture 1840 1847
High impedance 940 947
Premature Discharge of Battery 275 275
Naturally Worn 265 265
Low impedance 261 261
Device Contamination with Body Fluid 193 193
Electrical Shorting 159 159
Physical Resistance/Sticking 115 115
Inappropriate or Unexpected Reset 112 112
Incomplete or Inadequate Connection 112 112
Failure to Deliver Energy 104 104
Corroded 103 103
Insufficient Information 92 99
False Alarm 85 85
Output below Specifications 83 83
Failure to Interrogate 72 72
Therapeutic or Diagnostic Output Failure 63 63
Detachment of Device or Device Component 48 48
Material Twisted/Bent 40 40
Therapy Delivered to Incorrect Body Area 35 35
Defective Component 30 30
Device Contaminated During Manufacture or Shipping 29 29
Application Program Problem: Parameter Calculation Error 28 28
Electro-Static Discharge 25 25
No Apparent Adverse Event 22 22
Premature Elective Replacement Indicator 18 18
Migration 16 16
Battery Problem: High Impedance 12 12
Erratic or Intermittent Display 10 10
Premature End-of-Life Indicator 9 9
Energy Output Problem 5 5
Computer Software Problem 5 5
Mechanical Problem 4 4
Communication or Transmission Problem 4 4
Application Program Problem: Dose Calculation Error 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Protective Measures Problem 2 2
Appropriate Term/Code Not Available 2 2
Break 2 2
No Display/Image 1 1
Output Problem 1 1
Impedance Problem 1 1
Battery Problem 1 1
Degraded 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Defective Device 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 3453 3460
Convulsion, Clonic 1958 1958
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 466 467
Post Operative Wound Infection 458 507
Implant Pain 310 310
Discomfort 264 264
Neck Pain 172 172
Paralysis 171 221
Pocket Erosion 166 166
Insufficient Information 140 140
Skin Infection 135 135
Bradycardia 112 112
Chest Pain 111 111
Status Epilepticus 107 107
Wound Dehiscence 97 97
Dyspnea 86 86
Apnea 84 84
Vomiting 65 65
No Known Impact Or Consequence To Patient 64 64
Dysphagia/ Odynophagia 59 59
Unspecified Mental, Emotional or Behavioural Problem 58 58
Seizures 58 58
Cough 52 52
Paresis 50 99
Headache 48 48
Shock from Patient Lead(s) 47 47
Syncope/Fainting 46 46
Sleep Dysfunction 44 44
Cramp(s) /Muscle Spasm(s) 44 44
Asystole 35 35
Unspecified Heart Problem 35 35
Ambulation Difficulties 34 34
Tachycardia 32 32
Impaired Healing 31 31
Hemorrhage/Bleeding 29 29
Nausea 28 28
Fibrosis 28 28
Nerve Damage 27 27
Ecchymosis 26 26
Inflammation 26 26
Aspiration/Inhalation 25 25
Decreased Appetite 24 24
Unspecified Respiratory Problem 23 23
Depression 21 21
Cardiac Arrest 21 21
Extreme Exhaustion 19 19
Scar Tissue 19 19
Hypoesthesia 18 18
Dizziness 17 17
Weight Changes 17 18

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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