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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 2

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 1048 1104

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8903 8952
High impedance 3899 3906
Fracture 3336 3343
Insufficient Information 1492 1499
Device Operates Differently Than Expected 908 908
Premature End-of-Life Indicator 632 632
Battery Problem 533 533
Failure to Interrogate 516 516
Low impedance 498 498
Device Displays Incorrect Message 445 445
Device Inoperable 417 417
Communication or Transmission Problem 382 382
Break 372 372
Corroded 354 354
Premature Discharge of Battery 323 323
Device Contamination with Body Fluid 298 298
Mechanical Problem 294 294
Use of Incorrect Control/Treatment Settings 289 289
Programming Issue 251 251
Naturally Worn 220 220
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 103 103
Appropriate Term/Code Not Available 102 102
Failure to Charge 100 100
Detachment of Device or Device Component 100 100
Failure of Device to Self-Test 96 96
Electrical Shorting 96 96
Inappropriate or Unexpected Reset 95 95
Charging Problem 95 95
Energy Output To Patient Tissue Incorrect 95 95
False Alarm 90 90
Application Interface Becomes Non-Functional Or Program Exits Abnormally 82 82
Detachment Of Device Component 79 79
Failure to Deliver Energy 78 78
Material Protrusion/Extrusion 73 73
Incomplete or Inadequate Connection 72 72
Therapeutic or Diagnostic Output Failure 72 72
Output below Specifications 72 72
Physical Resistance/Sticking 70 70
Defective Component 64 64

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 2590 2597
Convulsion, Clonic 1485 1485
No Code Available 1391 1391
Unspecified Infection 1376 1376
Death 1181 1181
Pain 1021 1021
Therapeutic Response, Decreased 678 678
Paralysis 451 500
Neck Pain 428 428
Post Operative Wound Infection 418 467
Chest Pain 381 381
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 374 374
Discomfort 317 317
Dyspnea 275 275
No Information 266 266
Arrhythmia 266 266
Wound Dehiscence 264 264
Implant Pain 235 235
Apnea 232 233
Dysphagia/ Odynophagia 217 217
No Patient Involvement 178 178
Bradycardia 176 177
No Consequences Or Impact To Patient 171 171
Tissue Breakdown 169 169
Vomiting 159 159
Therapeutic Effects, Unexpected 142 142
Complaint, Ill-Defined 132 132
Pocket Erosion 130 130
Fall 130 130
Sleep Dysfunction 117 117
Muscle Spasm(s) 116 116
Paresis 111 160
Undesired Nerve Stimulation 111 111
Weight Changes 110 110
Insufficient Information 110 110
Syncope 100 100
Headache 95 95
Swelling 94 95
Fibrosis 91 91
Nerve Damage 90 90
Cardiac Arrest 83 83
Skin Infection 80 80
Pneumonia 77 77
Status Epilepticus 76 76
Impaired Healing 75 75
Depression 74 74
Cognitive Changes 72 72
Nausea 71 71

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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