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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
2020 74 74
2021 103 103
2022 105 105
2023 116 116
2024 78 78
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 381 381
Fracture 45 45
High impedance 33 33
Premature Discharge of Battery 11 11
Device Contamination with Body Fluid 9 9
Insufficient Information 7 7
Naturally Worn 7 7
Incomplete or Inadequate Connection 5 5
Corroded 5 5
Electro-Static Discharge 3 3
Low impedance 3 3
Output below Specifications 3 3
Failure to Deliver Energy 2 2
Physical Resistance/Sticking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
False Alarm 2 2
Computer Software Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Premature Elective Replacement Indicator 1 1
Output Problem 1 1
Energy Output Problem 1 1
Patient-Device Incompatibility 1 1
Battery Problem: Low Impedance 1 1
Application Program Problem: Parameter Calculation Error 1 1
Electrical Shorting 1 1
No Apparent Adverse Event 1 1
Erratic or Intermittent Display 1 1
Premature End-of-Life Indicator 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 108 108
No Clinical Signs, Symptoms or Conditions 79 79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 45 45
Paralysis 35 35
Suicidal Ideation 30 30
Post Operative Wound Infection 27 27
Neck Pain 25 25
Dyspnea 20 20
Discomfort 17 17
Implant Pain 16 16
Chest Pain 14 14
Unspecified Mental, Emotional or Behavioural Problem 14 14
Pain 12 12
Dysphagia/ Odynophagia 12 12
Syncope/Fainting 11 11
No Known Impact Or Consequence To Patient 11 11
Anxiety 11 11
Paresis 9 9
Arrhythmia 8 8
Hemorrhage/Bleeding 8 8
Headache 8 8
Insufficient Information 6 6
Vomiting 6 6
Apnea 6 6
Nausea 6 6
No Code Available 6 6
Unspecified Heart Problem 6 6
Tachycardia 6 6
Heart Failure/Congestive Heart Failure 5 5
Inflammation 5 5
Shock from Patient Lead(s) 5 5
Pocket Erosion 5 5
Ambulation Difficulties 5 5
Cramp(s) /Muscle Spasm(s) 4 4
Unspecified Respiratory Problem 4 4
Hypoesthesia 4 4
Pneumonia 4 4
Bradycardia 4 4
Fibrosis 4 4
Unspecified Infection 4 4
Low Blood Pressure/ Hypotension 4 4
Extreme Exhaustion 4 4
Edema 3 3
Aspiration/Inhalation 3 3
Cardiac Arrest 3 3
Dizziness 3 3
Fatigue 3 3
Death 3 3
Syncope 3 3
Wound Dehiscence 3 3

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