• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stimulator, autonomic nerve, implanted for epilepsy
Product CodeLYJ
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
14 9 3 7 6 1

MDR Year MDR Reports MDR Events
2016 2851 2851
2017 2074 2074
2018 2316 2316
2019 2432 2432
2020 1688 1688
2021 569 569

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5221 5221
Fracture 1857 1857
High impedance 1725 1725
Premature End-of-Life Indicator 623 623
Insufficient Information 403 403
Mechanical Problem 279 279
Corroded 263 263
Communication or Transmission Problem 260 260
Low impedance 250 250
Device Operates Differently Than Expected 244 244
Energy Output Problem 200 200
Computer Software Problem 189 189
Failure to Interrogate 180 180
Device Contamination with Body Fluid 154 154
Battery Problem 147 147
Device Displays Incorrect Message 145 145
Device Inoperable 105 105
Break 104 104
Incorrect, Inadequate or Imprecise Resultor Readings 102 102
Fluid Leak 99 99
Premature Discharge of Battery 93 93
Disconnection 91 91
Energy Output To Patient Tissue Incorrect 89 89
Appropriate Term/Code Not Available 79 79
Device Contaminated During Manufacture or Shipping 71 71
Detachment Of Device Component 62 62
Low Battery 60 60
Programming Issue 60 60
Detachment of Device or Device Component 55 55
Migration or Expulsion of Device 54 54
Failure to Power Up 47 47
Use of Incorrect Control Settings 45 45
Loose or Intermittent Connection 42 42
Unexpected Therapeutic Results 33 33
Connection Problem 26 26
Failure to Charge 25 25
Impedance Problem 23 23
No Display/Image 22 22
Material Protrusion/Extrusion 21 21
Charging Problem 21 21
Defective Component 21 21
Difficult to Insert 20 20
Therapeutic or Diagnostic Output Failure 20 20
Difficult to Interrogate 19 19
Output Problem 18 18
Defective Device 18 18
Naturally Worn 17 17
Bent 16 16
Loss of Power 15 15
Under-Sensing 15 15
Protective Measures Problem 14 14
Application Interface Becomes Non-Functional Or Program Exits Abnormally 14 14
Device Stops Intermittently 14 14
Improper or Incorrect Procedure or Method 14 14
Positioning Problem 14 14
Improper Device Output 13 13
Therapy Delivered to Incorrect Body Area 13 13
False Alarm 13 13
Inappropriate or Unexpected Reset 12 12
Extrusion 12 12
Malposition of Device 11 11
Output below Specifications 11 11
Inappropriate/Inadequate Shock/Stimulation 11 11
Battery Problem: High Impedance 11 11
Patient-Device Incompatibility 10 10
Computer Operating System Problem 9 9
Crack 9 9
Device Dislodged or Dislocated 9 9
Application Program Problem: Parameter Calculation Error 9 9
Device Sensing Problem 9 9
Failure of Device to Self-Test 8 8
Scratched Material 8 8
Over-Sensing 8 8
Component Missing 8 8
Device Slipped 7 7
Degraded 7 7
Device Expiration Issue 7 7
Nonstandard Device 7 7
Device Handling Problem 7 7
No Device Output 6 6
Device Operational Issue 6 6
Component Falling 6 6
Intermittent Continuity 6 6
Reset Problem 6 6
Data Problem 6 6
Moisture or Humidity Problem 6 6
Power Problem 6 6
Material Deformation 5 5
Image Display Error/Artifact 5 5
Electrical /Electronic Property Problem 5 5
Invalid Sensing 5 5
Use of Device Problem 5 5
Difficult to Remove 5 5
Failure to Shut Off 5 5
Physical Property Issue 5 5
Operating System Becomes Nonfunctional 4 4
Material Twisted/Bent 4 4
Failure to Advance 4 4
Sticking 4 4
Material Frayed 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4795 4795
Seizures 2437 2437
Unspecified Infection 964 964
No Code Available 937 937
Pain 712 712
Death 677 677
Chest Pain 264 264
Neck Pain 260 260
Arrhythmia 256 256
Paralysis 252 252
No Information 188 188
Tissue Breakdown 165 165
Dyspnea 161 161
No Clinical Signs, Symptoms or Conditions 159 159
Wound Dehiscence 154 154
Dysphagia/ Odynophagia 136 136
Apnea 109 110
Convulsion, Clonic 106 106
Muscle Spasm(s) 101 101
Vomiting 79 79
Syncope 75 75
Undesired Nerve Stimulation 71 71
Therapeutic Response, Decreased 67 67
Fibrosis 63 63
Cognitive Changes 63 63
Weight Changes 58 58
Edema 58 58
Nerve Damage 57 57
Paresis 56 56
Tissue Damage 51 51
Discomfort 49 49
Pneumonia 46 46
No Patient Involvement 45 45
No Consequences Or Impact To Patient 44 44
Sleep Dysfunction 44 44
Local Reaction 43 43
Ecchymosis 41 41
Bradycardia 41 42
Depression 41 41
Swelling 39 40
Fall 39 39
Fatigue 38 38
Post Operative Wound Infection 38 38
Headache 38 38
Impaired Healing 36 36
Nausea 35 35
Scarring 31 31
Inflammation 30 30
Hypoesthesia 27 27
Fluid Discharge 25 25
Hemorrhage/Bleeding 25 25
Aspiration/Inhalation 24 24
Scar Tissue 23 23
Anxiety 22 22
Dizziness 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Hematoma 21 21
Complaint, Ill-Defined 21 21
Seroma 21 21
Cardiac Arrest 20 20
Therapeutic Effects, Unexpected 19 19
Hypoxia 18 19
Numbness 17 17
Low Blood Pressure/ Hypotension 17 18
Ambulation Difficulties 17 17
Fever 16 16
Erythema 14 14
Seizures, Grand-Mal 14 14
Tachycardia 14 15
Injury 14 14
Ptosis 13 13
Emotional Changes 13 13
High Blood Pressure/ Hypertension 12 13
Inadequate Pain Relief 12 12
Pocket Erosion 12 12
Itching Sensation 12 12
Hearing Loss 11 11
Respiratory Distress 10 10
Twiddlers Syndrome 10 10
Burning Sensation 9 9
Choking 9 9
Electric Shock 9 9
Implant Pain 9 9
Loss of consciousness 9 10
Respiratory Failure 9 10
Shock from Patient Lead(s) 8 8
Discharge 8 8
Muscle Weakness 8 8
Constipation 8 8
Purulent Discharge 8 8
Bruise/Contusion 8 8
Asthma 8 8
Abdominal Pain 7 7
Diarrhea 7 7
Facial Nerve Paralysis 7 7
Urinary Retention 7 7
Patient Problem/Medical Problem 7 7
Twitching 7 7
Hemorrhage, Cerebral 7 7
Abscess 7 7

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 LivaNova USA Inc II Dec-04-2020
6 LivaNova USA Inc II Nov-17-2020
7 LivaNova USA Inc II Mar-24-2020
8 LivaNova USA Inc II Feb-10-2020
9 LivaNova USA Inc II Jan-27-2020
10 LivaNova USA Inc I Dec-20-2019
11 LivaNova USA Inc II Dec-10-2019
12 LivaNova USA Inc II Nov-07-2019
13 LivaNova USA Inc II Jul-28-2018
-
-