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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
2021 103 103
2022 105 105
2023 116 116
2024 78 79
2025 57 57
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 357 358
Fracture 42 42
High impedance 28 28
Premature Discharge of Battery 14 14
Insufficient Information 11 11
Device Contamination with Body Fluid 8 8
Naturally Worn 7 7
Incomplete or Inadequate Connection 4 4
Corroded 4 4
Electro-Static Discharge 3 3
Low impedance 3 3
Output below Specifications 3 3
Failure to Deliver Energy 2 2
Premature Elective Replacement Indicator 2 2
Physical Resistance/Sticking 2 2
False Alarm 2 2
Erratic or Intermittent Display 2 2
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Energy Output Problem 1 1
Patient-Device Incompatibility 1 1
Failure to Interrogate 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem 1 1
Battery Problem: Low Impedance 1 1
Application Program Problem: Parameter Calculation Error 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Electrical Shorting 1 1
No Apparent Adverse Event 1 1
Battery Problem: High Impedance 1 1
Inappropriate or Unexpected Reset 1 1
Therapy Delivered to Incorrect Body Area 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 99 99
No Clinical Signs, Symptoms or Conditions 93 93
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Suicidal Ideation 35 35
Paralysis 34 34
Post Operative Wound Infection 27 27
Implant Pain 20 20
Neck Pain 20 20
Dyspnea 18 18
Discomfort 16 16
Unspecified Mental, Emotional or Behavioural Problem 16 16
Syncope/Fainting 14 14
Paresis 11 11
Chest Pain 11 11
Dysphagia/ Odynophagia 11 11
Hemorrhage/Bleeding 8 8
Anxiety 8 8
Unspecified Heart Problem 7 7
Tachycardia 7 7
Insufficient Information 6 6
Headache 6 6
Bradycardia 6 6
Ambulation Difficulties 5 5
Pocket Erosion 5 5
Nausea 5 5
Vomiting 5 5
Inflammation 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Heart Failure/Congestive Heart Failure 5 5
Extreme Exhaustion 4 4
Low Blood Pressure/ Hypotension 4 4
Wound Dehiscence 4 4
Hypoesthesia 4 4
Shock from Patient Lead(s) 4 4
Nerve Damage 4 4
Pneumonia 4 4
Numbness 3 3
Pain 3 3
Partial Hearing Loss 3 3
Cardiac Arrest 3 3
Cough 3 3
Muscle Weakness 3 3
Aspiration/Inhalation 3 3
Dizziness 3 3
Unspecified Respiratory Problem 3 3
Convulsion, Clonic 3 3
Apnea 3 3
Atrial Flutter 3 3
Pulmonary Edema 2 2
Hypoxia 2 2

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