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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 (depression)
Definition The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Product CodeMUZ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 2 10 13 6 12 4 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 99 99
2015 102 102
2016 78 78
2017 54 54
2018 73 73
2019 84 84
2020 74 74
2021 103 103
2022 105 105
2023 116 116
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 505 505
Fracture 95 95
High impedance 86 86
Insufficient Information 59 59
Device Operates Differently Than Expected 30 30
Battery Problem 20 20
Corroded 17 17
Programming Issue 16 16
Unexpected Therapeutic Results 15 15
Use of Incorrect Control/Treatment Settings 14 14
Failure to Interrogate 12 12
Device Inoperable 12 12
Device Contamination with Body Fluid 12 12
Communication or Transmission Problem 12 12
Premature Discharge of Battery 10 10
Device Displays Incorrect Message 8 8
Migration or Expulsion of Device 7 7
Premature End-of-Life Indicator 7 7
Mechanical Problem 6 6
Computer Software Problem 6 6
Failure of Device to Self-Test 6 6
Low impedance 5 5
Naturally Worn 5 5
Incomplete or Inadequate Connection 5 5
Appropriate Term/Code Not Available 4 4
Low Battery 4 4
Material Protrusion/Extrusion 4 4
Failure to Charge 4 4
Difficult to Interrogate 4 4
Energy Output Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Energy Output To Patient Tissue Incorrect 3 3
Failure to Deliver Energy 3 3
Detachment of Device or Device Component 3 3
Output below Specifications 3 3
Computer Operating System Problem 3 3
Failure to Power Up 3 3
Patient-Device Incompatibility 3 3
Application Program Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Electro-Static Discharge 2 2
Connection Problem 2 2
Impedance Problem 2 2
Output Problem 2 2
Positioning Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Image Display Error/Artifact 2 2
Bent 2 2
False Alarm 2 2
Inadequacy of Device Shape and/or Size 2 2
Therapy Delivered to Incorrect Body Area 2 2
Loss of Power 2 2
Physical Resistance/Sticking 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Operating System Version or Upgrade Problem 1 1
Application Program Problem: Parameter Calculation Error 1 1
Misassembled 1 1
Unintended Collision 1 1
Leak/Splash 1 1
Looping 1 1
Loose or Intermittent Connection 1 1
Crack 1 1
Break 1 1
Detachment Of Device Component 1 1
Difficult to Insert 1 1
Fluid/Blood Leak 1 1
No Display/Image 1 1
Battery Problem: Low Impedance 1 1
Power Problem 1 1
Inappropriate or Unexpected Reset 1 1
Battery Problem: High Impedance 1 1
Electrical Shorting 1 1
Extrusion 1 1
Component Missing 1 1
Failure to Deliver 1 1
Failure to Align 1 1
Charging Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 193 193
No Known Impact Or Consequence To Patient 150 150
No Code Available 71 71
No Clinical Signs, Symptoms or Conditions 64 64
Pain 64 64
Paralysis 52 52
Death 48 48
Neck Pain 38 38
Therapeutic Response, Decreased 34 34
Dyspnea 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Suicidal Ideation 29 29
Discomfort 24 24
Post Operative Wound Infection 22 22
Chest Pain 21 21
Anxiety 20 20
Arrhythmia 17 17
Dysphagia/ Odynophagia 17 17
Unspecified Infection 16 16
Headache 15 15
Syncope 15 15
Paresis 13 13
Therapeutic Effects, Unexpected 13 13
No Information 11 11
Implant Pain 11 11
Syncope/Fainting 10 10
Complaint, Ill-Defined 9 9
Muscle Spasm(s) 9 9
Apnea 8 8
Unspecified Mental, Emotional or Behavioural Problem 8 8
Hypoesthesia 7 7
Cognitive Changes 7 7
Bradycardia 7 7
Hemorrhage/Bleeding 7 7
Fatigue 7 7
Nausea 7 7
Low Blood Pressure/ Hypotension 7 7
Tachycardia 6 6
Seizures 6 6
Edema 6 6
Sleep Dysfunction 6 6
Vomiting 6 6
Dizziness 6 6
Weight Changes 6 6
Heart Failure/Congestive Heart Failure 5 5
Unspecified Respiratory Problem 5 5
Ambulation Difficulties 5 5
Emotional Changes 5 5
Pocket Erosion 5 5
Inflammation 5 5
Undesired Nerve Stimulation 5 5
Nerve Damage 4 4
Scar Tissue 4 4
Pneumonia 4 4
Extreme Exhaustion 4 4
Wound Dehiscence 4 4
Tissue Damage 4 4
Unspecified Heart Problem 4 4
Insufficient Information 4 4
No Patient Involvement 4 4
Shock from Patient Lead(s) 4 4
Fibrosis 4 4
Irritability 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Numbness 3 3
Inadequate Pain Relief 3 3
Abdominal Pain 3 3
Aspiration/Inhalation 3 3
Atrial Flutter 3 3
Ecchymosis 2 2
Fever 2 2
Atherosclerosis 2 2
Atrial Fibrillation 2 2
Bronchitis 2 2
Cardiac Arrest 2 2
Respiratory Distress 2 2
Pulmonary Edema 2 2
Seroma 2 2
Shock 2 2
Swelling 2 2
Muscle Weakness 2 2
Myocardial Infarction 2 2
Liver Damage/Dysfunction 2 2
Hypoxia 2 2
Disability 2 2
Impaired Healing 2 2
Loss of consciousness 2 2
Choking 2 2
Palpitations 2 2
Irregular Pulse 2 2
Convulsion, Clonic 2 2
Skin Infection 2 2
Partial Hearing Loss 2 2
Tissue Breakdown 2 2
Thrombosis/Thrombus 2 2
Convulsion/Seizure 2 2
Constipation 1 1
Unspecified Vascular Problem 1 1
Fluid Discharge 1 1
Subcutaneous Nodule 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cyberonics, Inc II Jun-19-2018
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