• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 374 374
Fracture 41 41
High impedance 32 32
Premature Discharge of Battery 11 11
Device Contamination with Body Fluid 7 7
Insufficient Information 6 6
Corroded 5 5
Naturally Worn 5 5
Incomplete or Inadequate Connection 5 5
Output below Specifications 3 3
Low impedance 3 3
Electro-Static Discharge 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Deliver Energy 2 2
Computer Software Problem 2 2
Physical Resistance/Sticking 2 2
Therapeutic or Diagnostic Output Failure 2 2
False Alarm 2 2
Inappropriate or Unexpected Reset 1 1
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Therapy Delivered to Incorrect Body Area 1 1
Premature End-of-Life Indicator 1 1
Device Contaminated During Manufacture or Shipping 1 1
Battery Problem: Low Impedance 1 1
Application Program Problem: Parameter Calculation Error 1 1
Erratic or Intermittent Display 1 1
Premature Elective Replacement Indicator 1 1
Output Problem 1 1
Electrical Shorting 1 1
Energy Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 105 105
No Clinical Signs, Symptoms or Conditions 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Paralysis 34 34
Suicidal Ideation 30 30
Post Operative Wound Infection 27 27
Neck Pain 25 25
Dyspnea 20 20
Discomfort 17 17
Implant Pain 15 15
Chest Pain 14 14
Unspecified Mental, Emotional or Behavioural Problem 13 13
Pain 12 12
Dysphagia/ Odynophagia 11 11
No Known Impact Or Consequence To Patient 11 11
Anxiety 10 10
Syncope/Fainting 10 10
Paresis 9 9
Arrhythmia 8 8
Headache 8 8
Hemorrhage/Bleeding 8 8
Nausea 6 6
Apnea 6 6
Unspecified Heart Problem 6 6
Insufficient Information 6 6
No Code Available 6 6
Ambulation Difficulties 5 5
Pocket Erosion 5 5
Heart Failure/Congestive Heart Failure 5 5
Tachycardia 5 5
Shock from Patient Lead(s) 5 5
Vomiting 5 5
Inflammation 5 5
Pneumonia 4 4
Hypoesthesia 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Unspecified Infection 4 4
Low Blood Pressure/ Hypotension 4 4
Extreme Exhaustion 4 4
Bradycardia 4 4
Unspecified Respiratory Problem 4 4
Dizziness 3 3
Fibrosis 3 3
Fatigue 3 3
Edema 3 3
Death 3 3
Cardiac Arrest 3 3
Atrial Flutter 3 3
Aspiration/Inhalation 3 3
Partial Hearing Loss 3 3

-
-