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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

MDR Year MDR Reports MDR Events
2017 54 54
2018 73 73
2019 84 84
2020 74 74
2021 103 103
2022 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 311 311
Fracture 73 73
High impedance 34 34
Corroded 14 14
Device Contamination with Body Fluid 11 11
Premature End-of-Life Indicator 7 7
Insufficient Information 7 7
Mechanical Problem 6 6
Computer Software Problem 4 4
Naturally Worn 4 4
Detachment of Device or Device Component 3 3
Energy Output Problem 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Low impedance 2 2
Therapy Delivered to Incorrect Body Area 2 2
Communication or Transmission Problem 2 2
Output below Specifications 2 2
Appropriate Term/Code Not Available 2 2
Incomplete or Inadequate Connection 2 2
Physical Resistance/Sticking 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Inappropriate or Unexpected Reset 1 1
Low Battery 1 1
Detachment Of Device Component 1 1
Difficult to Insert 1 1
Energy Output To Patient Tissue Incorrect 1 1
Failure to Deliver Energy 1 1
Fluid Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 97 97
No Known Impact Or Consequence To Patient 69 69
No Code Available 53 53
Pain 40 40
No Clinical Signs, Symptoms or Conditions 27 27
Paralysis 26 26
Neck Pain 25 25
Dyspnea 16 16
Arrhythmia 15 15
Chest Pain 15 15
Anxiety 15 15
Unspecified Infection 14 14
Suicidal Ideation 13 13
Post Operative Wound Infection 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Syncope 10 10
Dysphagia/ Odynophagia 10 10
Headache 8 8
Discomfort 8 8
Low Blood Pressure/ Hypotension 7 7
Hemorrhage/Bleeding 6 6
Paresis 6 6
Muscle Spasm(s) 6 6
Implant Pain 6 6
No Information 5 5
Fatigue 5 5
Death 5 5
Edema 5 5
Hypoesthesia 5 5
Seizures 5 5
Inflammation 4 4
Dizziness 4 4
Tissue Damage 4 4
Apnea 4 4
Nausea 4 4
Wound Dehiscence 3 3
Pocket Erosion 3 3
Tachycardia 3 3
Sleep Dysfunction 3 3
Cognitive Changes 3 3
Shock from Patient Lead(s) 3 3
Fibrosis 3 3
Insufficient Information 3 3
Syncope/Fainting 3 3
Unspecified Respiratory Problem 2 2
Tissue Breakdown 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Thrombosis/Thrombus 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Heart Problem 2 2
Ambulation Difficulties 2 2
Numbness 2 2
Irritability 2 2
Pulmonary Edema 2 2
Vomiting 2 2
Impaired Healing 2 2
Atrial Flutter 2 2
Emotional Changes 2 2
Ecchymosis 2 2
Aspiration/Inhalation 2 2
Nerve Damage 2 2
Undesired Nerve Stimulation 2 2
Extreme Exhaustion 2 2
Fever 1 1
Foreign Body Reaction 1 1
Hemorrhage, Cerebral 1 1
High Blood Pressure/ Hypertension 1 1
Pneumonia 1 1
Atrial Fibrillation 1 1
Eructate 1 1
Bradycardia 1 1
Bronchitis 1 1
Cardiac Arrest 1 1
Abdominal Pain 1 1
Sore Throat 1 1
Scar Tissue 1 1
Tinnitus 1 1
Sepsis 1 1
Seroma 1 1
Irregular Pulse 1 1
No Patient Involvement 1 1
Cough 1 1
Fluid Discharge 1 1
Partial Hearing Loss 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1
Subcutaneous Nodule 1 1

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