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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)
2015 2016 2017 2018 2019 2020
2 14 9 3 7 6

MDR Year MDR Reports MDR Events
2015 3265 3265
2016 2849 2849
2017 2074 2074
2018 2316 2316
2019 2432 2432
2020 1411 1411

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5114 5114
High impedance 2380 2380
Fracture 1747 1747
Insufficient Information 816 816
Premature End-of-Life Indicator 614 614
Device Operates Differently Than Expected 589 589
Cable, Electrical 362 362
Device Displays Incorrect Message 351 351
Failure to Interrogate 338 338
Battery Problem 324 324
Communication or Transmission Problem 317 317
Patient Lead 285 285
Mechanical Problem 274 274
Low impedance 266 266
Corroded 258 258
Device Inoperable 244 244
Break 214 214
Energy Output Problem 190 190
Computer Software Problem 189 189
Generator 152 152
Device Contamination with Body Fluid 138 138
Programming Issue 135 135
Use of Incorrect Control Settings 134 134
Disconnection 134 134
Battery 113 113
Premature Discharge of Battery 110 110
Migration or Expulsion of Device 109 109
Handpiece 108 108
Fluid Leak 105 105
Failure to Power Up 105 105
Incorrect, Inadequate or Imprecise Resultor Readings 97 97
Energy Output To Patient Tissue Incorrect 94 94
Appropriate Term/Code Not Available 88 88
Low Battery 84 84
Wire 82 82
Loose or Intermittent Connection 82 82
Failure to Charge 76 76
Unexpected Therapeutic Results 74 74
Device Contaminated During Manufacture or Shipping 70 70
Detachment Of Device Component 70 70
Screen 57 57
Port 55 55
Detachment of Device or Device Component 54 54
Improper or Incorrect Procedure or Method 51 51
Material Protrusion/Extrusion 47 47
Connection Problem 44 44
Charging Problem 43 43
Difficult to Interrogate 41 41
Failure of Device to Self-Test 40 40
Defective Component 39 39
Application Interface Becomes Non-Functional Or Program Exits Abnormally 39 39
No Display/Image 36 36
Operating System Becomes Nonfunctional 33 33
Extrusion 30 30
Loss of Power 29 29
Positioning Problem 28 28
Malposition of Device 28 28
Impedance Problem 27 27
Pin 24 24
Difficult to Insert 24 24
Output Problem 23 23
Therapeutic or Diagnostic Output Failure 23 23
Defective Device 22 22
Component Missing 22 22
Bent 22 22
Device Stops Intermittently 22 22
Inappropriate/Inadequate Shock/Stimulation 20 20
Human-Device Interface Problem 20 20
Computer Operating System Problem 18 18
Crack 17 17
Image Display Error/Artifact 17 17
Intermittent Continuity 16 16
Improper Device Output 16 16
Insulation 16 16
Failure to Sense 16 16
Device Slipped 16 16
Under-Sensing 16 16
Patient-Device Incompatibility 16 16
Adapter (Adaptor) 15 15
Scratched Material 15 15
Device Sensing Problem 14 14
Connector 14 14
Material Frayed 14 14
Therapy Delivered to Incorrect Body Area 14 14
Switch, Push Button 14 14
Electrode 14 14
Degraded 14 14
Battery Problem: High Impedance 14 14
Protective Measures Problem 14 14
Electrical /Electronic Property Problem 13 13
Component Falling 13 13
Failure to Advance 12 12
Tube 12 12
Device Expiration Issue 12 12
Difficult to Open or Close 11 11
Device Dislodged or Dislocated 11 11
Moisture or Humidity Problem 11 11
Unable to Obtain Readings 10 10
Difficult to Remove 10 10
Display 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6033 6033
Seizures 2873 2873
No Code Available 1147 1147
Unspecified Infection 1103 1103
Death 873 873
Pain 848 848
Therapeutic Response, Decreased 319 319
Paralysis 276 276
Chest Pain 255 255
Neck Pain 254 254
Arrhythmia 241 241
No Information 227 227
Dyspnea 178 178
Wound Dehiscence 167 167
Tissue Breakdown 160 160
Dysphagia/ Odynophagia 143 143
No Patient Involvement 134 134
Apnea 128 129
Muscle Spasm(s) 105 105
No Consequences Or Impact To Patient 104 104
Undesired Nerve Stimulation 99 99
Complaint, Ill-Defined 84 84
Discomfort 83 83
Vomiting 82 82
Weight Changes 77 77
Syncope 77 77
Fall 66 66
Swelling 65 66
Therapeutic Effects, Unexpected 64 64
Fibrosis 64 64
Cognitive Changes 61 61
Sleep Dysfunction 60 60
Bradycardia 59 60
Paresis 58 58
Edema 54 54
Pneumonia 54 54
Tissue Damage 53 53
Nerve Damage 51 51
Depression 45 45
Impaired Healing 43 43
Local Reaction 41 41
Headache 41 41
Nausea 38 38
Ecchymosis 36 36
Cardiac Arrest 36 36
Fatigue 36 36
Scarring 35 35
Seizures, Grand-Mal 33 33
Inflammation 32 32
Erythema 31 31
Aspiration/Inhalation 30 30
Fluid Discharge 30 30
Inadequate Pain Relief 30 30
Hemorrhage/Bleeding 30 30
Scar Tissue 30 30
Injury 28 28
Dizziness 28 28
Anxiety 26 26
Hypoxia 25 26
Hypoesthesia 25 25
Hematoma 24 24
Seroma 24 24
Fever 23 23
Numbness 23 23
Twiddlers Syndrome 22 22
Low Blood Pressure/ Hypotension 21 22
Respiratory Distress 20 20
Choking 20 20
Tachycardia 19 20
Purulent Discharge 19 19
Emotional Changes 19 19
Loss of consciousness 19 20
Dysphasia 18 18
Ambulation Difficulties 17 17
Staphylococcus Aureus 17 17
Burning Sensation 16 16
Electric Shock 15 15
Bruise/Contusion 14 14
Itching Sensation 14 14
Erosion 14 14
Shock from Patient Lead(s) 14 14
Post Operative Wound Infection 13 13
Ptosis 12 12
Tingling 12 12
High Blood Pressure/ Hypertension 12 13
Discharge 12 12
Hearing Loss 11 11
Respiratory Failure 11 12
Brain Injury 11 11
Shock 11 11
Pocket Erosion 10 10
Asthma 10 10
Reaction 10 10
Coma 10 10
Device Overstimulation of Tissue 10 10
Irritation 10 10
Sepsis 9 9
Patient Problem/Medical Problem 9 9
Abdominal Pain 9 9
Abscess 8 8

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 LivaNova USA Inc II Nov-17-2020
8 LivaNova USA Inc II Mar-24-2020
9 LivaNova USA Inc II Feb-10-2020
10 LivaNova USA Inc II Jan-27-2020
11 LivaNova USA Inc I Dec-20-2019
12 LivaNova USA Inc II Dec-10-2019
13 LivaNova USA Inc II Nov-07-2019
14 LivaNova USA Inc II Jul-28-2018
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