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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)
2019 2020 2021 2022 2023 2024
7 6 1 3 5 1

MDR Year MDR Reports MDR Events
2019 2432 2432
2020 1688 1688
2021 1764 1764
2022 1584 1584
2023 1764 1764
2024 349 349

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5136 5136
Fracture 1981 1981
High impedance 1136 1136
Low impedance 266 266
Premature End-of-Life Indicator 239 239
Device Contamination with Body Fluid 225 225
Premature Discharge of Battery 195 195
Naturally Worn 174 174
Corroded 163 163
Energy Output Problem 155 155
Computer Software Problem 142 142
Mechanical Problem 100 100
Incorrect, Inadequate or Imprecise Result or Readings 86 86
False Alarm 84 84
Insufficient Information 77 77
Detachment of Device or Device Component 76 76
Inappropriate or Unexpected Reset 73 73
Electrical Shorting 69 69
Device Contaminated During Manufacture or Shipping 66 66
Failure to Interrogate 63 63
Incomplete or Inadequate Connection 62 62
Output below Specifications 59 59
Physical Resistance/Sticking 54 54
Therapeutic or Diagnostic Output Failure 50 50
Failure to Deliver Energy 46 46
Application Program Problem: Parameter Calculation Error 29 29
Material Twisted/Bent 29 29
Therapy Delivered to Incorrect Body Area 23 23
Defective Component 21 21
Communication or Transmission Problem 20 20
No Apparent Adverse Event 19 19
Appropriate Term/Code Not Available 12 12
Electro-Static Discharge 12 12
Migration 7 7
Over-Sensing 7 7
Premature Elective Replacement Indicator 7 7
Battery Problem: High Impedance 7 7
Protective Measures Problem 5 5
Nonstandard Device 4 4
Output Problem 4 4
Break 3 3
Erratic or Intermittent Display 3 3
No Display/Image 3 3
Defective Device 2 2
Under-Sensing 2 2
Computer Operating System Problem 1 1
Unexpected Shutdown 1 1
Electromagnetic Interference 1 1
Device-Device Incompatibility 1 1
Labelling, Instructions for Use or Training Problem 1 1
Crack 1 1
Failure to Deliver Shock/Stimulation 1 1
Impedance Problem 1 1
Loose or Intermittent Connection 1 1
Entrapment of Device 1 1
Firing Problem 1 1
Scratched Material 1 1
Device Dislodged or Dislocated 1 1
Application Program Problem: Dose Calculation Error 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1
Unintended Electrical Shock 1 1
Patient-Device Incompatibility 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2251 2251
No Known Impact Or Consequence To Patient 1709 1709
Convulsion, Clonic 1336 1336
Seizures 1069 1069
No Code Available 367 367
Unspecified Infection 367 367
Post Operative Wound Infection 349 349
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 324 324
Pain 269 269
Neck Pain 226 226
Paralysis 223 223
Chest Pain 200 200
Implant Pain 199 199
Discomfort 165 165
Death 144 144
Arrhythmia 130 130
Dyspnea 124 124
Wound Dehiscence 115 115
Pocket Erosion 107 107
Apnea 106 106
Dysphagia/ Odynophagia 98 98
Insufficient Information 95 95
Vomiting 82 82
Tissue Breakdown 80 80
Bradycardia 76 76
Status Epilepticus 66 66
Skin Infection 60 60
Paresis 56 56
Headache 53 53
Sleep Dysfunction 52 52
Muscle Spasm(s) 51 51
Nerve Damage 46 46
No Information 44 44
Unspecified Mental, Emotional or Behavioural Problem 42 42
Weight Changes 40 40
Cough 40 40
Impaired Healing 37 37
Depression 37 37
Ecchymosis 36 36
Ambulation Difficulties 34 34
Syncope 34 34
Fibrosis 33 33
Nausea 33 33
Shock from Patient Lead(s) 31 31
Cognitive Changes 31 31
Edema 30 30
Hemorrhage/Bleeding 29 29
Aspiration/Inhalation 29 29
Cramp(s) /Muscle Spasm(s) 29 29
Inflammation 28 28
Asystole 28 28
Syncope/Fainting 26 26
Local Reaction 26 26
Tissue Damage 25 25
Tachycardia 25 25
Unspecified Heart Problem 23 23
Hypoesthesia 23 23
Pneumonia 23 23
Dizziness 21 21
Decreased Appetite 20 20
Fatigue 20 20
Unspecified Respiratory Problem 19 19
Undesired Nerve Stimulation 17 17
Hypoxia 17 17
Scarring 16 16
Anxiety 16 16
Scar Tissue 15 15
Cardiac Arrest 15 15
Extreme Exhaustion 13 13
Numbness 13 13
Muscle Weakness 12 12
No Patient Involvement 10 10
Foreign Body Reaction 10 10
Ptosis 10 10
Low Blood Pressure/ Hypotension 10 10
Hematoma 10 10
High Blood Pressure/ Hypertension 8 8
Aspiration Pneumonitis 8 8
Atrial Fibrillation 8 8
Constipation 8 8
Abdominal Pain 8 8
Twitching 8 8
Choking 8 8
Emotional Changes 8 8
Sepsis 7 7
Failure of Implant 7 7
Seroma 7 7
Hearing Loss 6 6
Diarrhea 6 6
Itching Sensation 6 6
Erythema 6 6
Subcutaneous Nodule 6 6
Hiccups 6 6
Septic Shock 6 6
Convulsion/Seizure 6 6
Suicidal Ideation 5 5
Gastrointestinal Hemorrhage 5 5
Confusion/ Disorientation 5 5
Urinary Retention 5 5
Fever 5 5

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 I Dec-20-2019
7 LivaNova USA Inc II Dec-10-2019
8 LivaNova USA Inc II Nov-07-2019
9 LivaNova USA, Inc. II Jan-28-2022
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