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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 0

MDR Year MDR Reports MDR Events
2019 2432 2432
2020 1688 1688
2021 1764 1764
2022 1584 1584
2023 1764 1764
2024 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5011 5011
Fracture 1914 1914
High impedance 1085 1085
Low impedance 256 256
Premature End-of-Life Indicator 239 239
Device Contamination with Body Fluid 213 213
Premature Discharge of Battery 187 187
Corroded 162 162
Naturally Worn 161 161
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 75 75
Detachment of Device or Device Component 75 75
Inappropriate or Unexpected Reset 72 72
Device Contaminated During Manufacture or Shipping 66 66
Electrical Shorting 61 61
Incomplete or Inadequate Connection 59 59
Output below Specifications 58 58
Failure to Interrogate 58 58
Therapeutic or Diagnostic Output Failure 50 50
Physical Resistance/Sticking 50 50
Failure to Deliver Energy 43 43
Application Program Problem: Parameter Calculation Error 29 29
Material Twisted/Bent 25 25
Therapy Delivered to Incorrect Body Area 23 23
Communication or Transmission Problem 20 20
Defective Component 18 18
No Apparent Adverse Event 16 16
Appropriate Term/Code Not Available 12 12
Electro-Static Discharge 11 11
Over-Sensing 7 7
Migration 7 7
Battery Problem: High Impedance 6 6
Premature Elective Replacement Indicator 6 6
Protective Measures Problem 5 5
Output Problem 4 4
Nonstandard Device 4 4
Break 3 3
Erratic or Intermittent Display 3 3
No Display/Image 3 3
Under-Sensing 2 2
Defective Device 2 2
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Migration or Expulsion of Device 1 1
Application Program Problem: Dose Calculation Error 1 1
Electromagnetic Interference 1 1
Entrapment of Device 1 1
Failure to Deliver Shock/Stimulation 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Labelling, Instructions for Use or Training Problem 1 1
Scratched Material 1 1
Impedance Problem 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Computer Operating System Problem 1 1
Firing Problem 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2106 2106
No Known Impact Or Consequence To Patient 1709 1709
Convulsion, Clonic 1285 1285
Seizures 1069 1069
No Code Available 367 367
Unspecified Infection 367 367
Post Operative Wound Infection 344 344
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 304 304
Pain 268 268
Neck Pain 223 223
Paralysis 218 218
Chest Pain 200 200
Implant Pain 188 188
Discomfort 152 152
Death 144 144
Arrhythmia 130 130
Dyspnea 122 122
Wound Dehiscence 113 113
Apnea 105 105
Pocket Erosion 101 101
Dysphagia/ Odynophagia 96 96
Insufficient Information 89 89
Tissue Breakdown 80 80
Vomiting 78 78
Bradycardia 72 72
Status Epilepticus 64 64
Paresis 56 56
Skin Infection 55 55
Headache 52 52
Muscle Spasm(s) 51 51
Sleep Dysfunction 50 50
Nerve Damage 44 44
No Information 44 44
Weight Changes 39 39
Unspecified Mental, Emotional or Behavioural Problem 39 39
Cough 39 39
Depression 37 37
Ecchymosis 36 36
Impaired Healing 36 36
Syncope 34 34
Fibrosis 32 32
Nausea 32 32
Ambulation Difficulties 32 32
Cognitive Changes 31 31
Shock from Patient Lead(s) 30 30
Edema 30 30
Aspiration/Inhalation 29 29
Asystole 28 28
Cramp(s) /Muscle Spasm(s) 28 28
Hemorrhage/Bleeding 28 28
Inflammation 27 27
Syncope/Fainting 26 26
Local Reaction 26 26
Tissue Damage 25 25
Tachycardia 25 25
Hypoesthesia 23 23
Pneumonia 23 23
Unspecified Heart Problem 22 22
Dizziness 20 20
Fatigue 20 20
Unspecified Respiratory Problem 19 19
Decreased Appetite 19 19
Undesired Nerve Stimulation 17 17
Hypoxia 17 17
Scarring 16 16
Scar Tissue 15 15
Anxiety 15 15
Cardiac Arrest 13 13
Extreme Exhaustion 12 12
Numbness 12 12
Muscle Weakness 12 12
No Patient Involvement 10 10
Ptosis 10 10
Low Blood Pressure/ Hypotension 10 10
Hematoma 9 9
High Blood Pressure/ Hypertension 8 8
Aspiration Pneumonitis 8 8
Choking 8 8
Emotional Changes 8 8
Twitching 8 8
Foreign Body Reaction 8 8
Constipation 8 8
Abdominal Pain 8 8
Sepsis 7 7
Atrial Fibrillation 7 7
Seroma 7 7
Hearing Loss 6 6
Itching Sensation 6 6
Subcutaneous Nodule 6 6
Failure of Implant 6 6
Septic Shock 6 6
Convulsion/Seizure 5 5
Suicidal Ideation 5 5
Confusion/ Disorientation 5 5
Urinary Retention 5 5
Fever 5 5
Erythema 5 5
Diarrhea 4 4
Fluid Discharge 4 4
Tinnitus 4 4

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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