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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 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 364 365
Fracture 44 44
High impedance 28 28
Premature Discharge of Battery 15 15
Insufficient Device Problem Information 11 11
Device Contamination with Body Fluid 8 8
Naturally Worn 7 7
Incomplete or Inadequate Connection 5 5
Corroded 4 4
Erratic or Intermittent Display 4 4
Output below Specifications 3 3
Premature Elective Replacement Indicator 3 3
Low impedance 3 3
Electrostatic Discharge 3 3
Failure to Deliver Energy 2 2
False Alarm 2 2
Physical Resistance/Sticking 2 2
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem: High Impedance 1 1
Application Program Problem: Parameter Calculation Error 1 1
Therapy Delivered to Incorrect Body Area 1 1
Inappropriate or Unexpected Reset 1 1
Electrical Shorting 1 1
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Failure to Interrogate 1 1
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 99 99
No Clinical Signs, Symptoms or Conditions 98 98
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 52 52
Suicidal Ideation 36 36
Paralysis 34 34
Post Operative Wound Infection 27 27
Neck Pain 20 20
Implant 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/Blood Loss/Bleeding 9 9
Anxiety 8 8
Unspecified Heart Problem 7 7
Tachycardia 7 7
Headache 6 6
Bradycardia 6 6
Insufficient Information 6 6
Heart Failure/Congestive Heart Failure 5 5
Pneumonia 5 5
Inflammation 5 5
Ambulation or Postural Difficulties 5 5
Pocket Erosion 5 5
Vomiting 5 5
Nausea 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Low Blood Pressure/ Hypotension 4 4
Shock from Patient Lead(s) 4 4
Hypoesthesia 4 4
Nerve Damage 4 4
Wound Dehiscence 4 4
Extreme Exhaustion 4 4
Partial Hearing Loss 3 3
Medical device site infection 3 3
Muscle Weakness/Atrophy 3 3
Numbness 3 3
Aspiration/Inhalation 3 3
Convulsion, Clonic 3 3
Cough 3 3
Dizziness 3 3
Atrial Flutter 3 3
Apnea 3 3
Unspecified Respiratory Problem 3 3
Pain 3 3
Seroma 3 3
Cardiac Arrest 3 3

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