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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 10 24 0 0 0 2 14 9 3 7 6 1 3 5 1

MDR Year MDR Reports MDR Events
2014 3365 3365
2015 3265 3265
2016 2854 2854
2017 2074 2074
2018 2317 2317
2019 2432 2432
2020 1688 1688
2021 1764 1764
2022 1584 1584
2023 1764 1764
2024 476 476

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8631 8631
High impedance 3814 3814
Fracture 3172 3172
Insufficient Information 1484 1484
Device Operates Differently Than Expected 908 908
Premature End-of-Life Indicator 632 632
Battery Problem 533 533
Failure to Interrogate 512 512
Low impedance 476 476
Device Displays Incorrect Message 445 445
Device Inoperable 417 417
Communication or Transmission Problem 382 382
Break 372 372
Corroded 347 347
Premature Discharge of Battery 314 314
Mechanical Problem 294 294
Use of Incorrect Control/Treatment Settings 289 289
Device Contamination with Body Fluid 288 288
Programming Issue 251 251
Naturally Worn 201 201
Computer Software Problem 201 201
Energy Output Problem 201 201
Unexpected Therapeutic Results 171 171
Migration or Expulsion of Device 152 152
Failure to Power Up 146 146
Disconnection 144 144
Loose or Intermittent Connection 117 117
Low Battery 109 109
Fluid/Blood Leak 108 108
Improper or Incorrect Procedure or Method 108 108
Incorrect, Inadequate or Imprecise Result or Readings 104 104
Device Contaminated During Manufacture or Shipping 102 102
Appropriate Term/Code Not Available 102 102
Failure to Charge 100 100
Detachment of Device or Device Component 98 98
Failure of Device to Self-Test 96 96
Charging Problem 95 95
Energy Output To Patient Tissue Incorrect 95 95
False Alarm 86 86
Inappropriate or Unexpected Reset 86 86
Application Interface Becomes Non-Functional Or Program Exits Abnormally 82 82
Detachment Of Device Component 79 79
Electrical Shorting 75 75
Material Protrusion/Extrusion 73 73
Therapeutic or Diagnostic Output Failure 71 71
Output below Specifications 69 69
Failure to Deliver Energy 67 67
Incomplete or Inadequate Connection 66 66
Defective Component 64 64
Connection Problem 60 60
Physical Resistance/Sticking 58 58
Operating System Becomes Nonfunctional 58 58
No Display/Image 55 55
Malposition of Device 53 53
Positioning Problem 51 51
Difficult to Interrogate 47 47
Extrusion 46 46
Loss of Power 44 44
Material Twisted/Bent 42 42
Device Stops Intermittently 40 40
Therapy Delivered to Incorrect Body Area 34 34
Difficult to Insert 34 34
Output Problem 34 34
Device Dislodged or Dislocated 33 33
Impedance Problem 31 31
Crack 30 30
Application Program Problem: Parameter Calculation Error 30 30
Inappropriate/Inadequate Shock/Stimulation 30 30
Bent 29 29
Human-Device Interface Problem 29 29
Scratched Material 27 27
Material Frayed 26 26
Component Missing 24 24
Defective Device 24 24
Failure to Advance 23 23
Battery Problem: High Impedance 22 22
Device Slipped 22 22
Image Display Error/Artifact 21 21
Intermittent Continuity 20 20
Improper Device Output 20 20
No Apparent Adverse Event 20 20
Patient-Device Incompatibility 19 19
Computer Operating System Problem 19 19
Electrical /Electronic Property Problem 19 19
Failure to Sense 19 19
Moisture or Humidity Problem 18 18
Device Expiration Issue 17 17
Degraded 17 17
Component Falling 16 16
Under-Sensing 16 16
Protective Measures Problem 16 16
Difficult to Open or Close 15 15
Device Sensing Problem 15 15
Electro-Static Discharge 15 15
Leak/Splash 15 15
Sticking 14 14
Reset Problem 14 14
Kinked 13 13
Use of Device Problem 12 12
Difficult to Remove 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7536 7536
Seizures 3758 3758
No Clinical Signs, Symptoms or Conditions 2302 2302
No Code Available 1391 1391
Unspecified Infection 1376 1376
Convulsion, Clonic 1373 1373
Death 1181 1181
Pain 1021 1021
Therapeutic Response, Decreased 678 678
Paralysis 439 439
Neck Pain 421 421
Post Operative Wound Infection 385 385
Chest Pain 380 380
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 334 334
Discomfort 291 291
Dyspnea 270 270
Arrhythmia 266 266
No Information 266 266
Wound Dehiscence 258 258
Apnea 224 225
Dysphagia/ Odynophagia 213 213
Implant Pain 206 206
No Patient Involvement 178 178
No Consequences Or Impact To Patient 171 171
Tissue Breakdown 169 169
Bradycardia 166 167
Vomiting 154 154
Therapeutic Effects, Unexpected 142 142
Complaint, Ill-Defined 132 132
Fall 130 130
Pocket Erosion 121 121
Muscle Spasm(s) 116 116
Undesired Nerve Stimulation 111 111
Sleep Dysfunction 111 111
Weight Changes 110 110
Paresis 106 106
Insufficient Information 102 102
Syncope 100 100
Headache 94 94
Swelling 94 95
Nerve Damage 90 90
Fibrosis 90 90
Cardiac Arrest 80 80
Pneumonia 76 76
Depression 74 74
Impaired Healing 73 73
Cognitive Changes 72 72
Nausea 68 68
Status Epilepticus 67 67
Skin Infection 65 65
Erythema 62 62
Inflammation 61 61
Tissue Damage 60 60
Edema 60 60
Aspiration/Inhalation 59 59
Ecchymosis 58 58
Hemorrhage/Bleeding 58 58
Shock from Patient Lead(s) 56 56
Seizures, Grand-Mal 53 53
Tachycardia 51 52
Local Reaction 51 51
Scar Tissue 49 49
Fatigue 47 47
Ambulation Difficulties 47 47
Dizziness 45 45
Injury 44 44
Unspecified Mental, Emotional or Behavioural Problem 44 44
Hematoma 43 43
Scarring 41 41
Fever 40 40
Cough 40 40
Anxiety 40 40
Hypoesthesia 40 40
Hypoxia 38 39
Numbness 35 35
Dysphasia 35 35
Choking 35 35
Fluid Discharge 35 35
Staphylococcus Aureus 34 34
Loss of consciousness 33 34
Inadequate Pain Relief 31 31
Seroma 31 31
Low Blood Pressure/ Hypotension 30 31
Cramp(s) /Muscle Spasm(s) 30 30
Purulent Discharge 29 29
Syncope/Fainting 29 29
Asystole 28 28
Respiratory Distress 27 27
Twiddlers Syndrome 26 26
Emotional Changes 25 25
Burning Sensation 24 24
Unspecified Heart Problem 24 24
Electric Shock 24 24
Abscess 21 21
Decreased Appetite 21 21
Bruise/Contusion 20 20
Unspecified Respiratory Problem 20 20
Tingling 20 20
Twitching 20 20
Sepsis 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Cyberonics, Inc II Feb-08-2018
2 Cyberonics, Inc II Aug-11-2017
3 Cyberonics, Inc II Jan-15-2016
4 Cyberonics, Inc II Jan-13-2016
5 Cyberonics, Inc II Nov-17-2015
6 Cyberonics, Inc II Apr-27-2015
7 Cyberonics, Inc II Dec-23-2014
8 Cyberonics, Inc II Nov-18-2011
9 Cyberonics, Inc II Oct-04-2011
10 Cyberonics, Inc II May-10-2010
11 Cyberonics, Inc II Jan-14-2010
12 Cyberonics, Inc II Nov-16-2009
13 Cyberonics, Inc III Apr-22-2009
14 LivaNova USA Inc II Dec-04-2020
15 LivaNova USA Inc II Nov-17-2020
16 LivaNova USA Inc II Mar-24-2020
17 LivaNova USA Inc II Feb-10-2020
18 LivaNova USA Inc II Jan-27-2020
19 LivaNova USA Inc I Dec-20-2019
20 LivaNova USA Inc II Dec-10-2019
21 LivaNova USA Inc II Nov-07-2019
22 LivaNova USA Inc II Jul-28-2018
23 LivaNova USA, Inc. II Jan-28-2022
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