Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 402 402
Fracture 47 47
High impedance 35 35
Premature Discharge of Battery 13 13
Device Contamination with Body Fluid 9 9
Insufficient Information 9 9
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
Energy Output Problem 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
Erratic or Intermittent Display 2 2
Therapy Delivered to Incorrect Body Area 2 2
Device Contaminated During Manufacture or Shipping 1 1
Premature Elective Replacement Indicator 1 1
Output Problem 1 1
Patient-Device Incompatibility 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
Premature End-of-Life Indicator 1 1
Inappropriate or Unexpected Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Depression 114 114
No Clinical Signs, Symptoms or Conditions 87 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 47 47
Paralysis 36 36
Suicidal Ideation 34 34
Post Operative Wound Infection 27 27
Neck Pain 25 25
Dyspnea 21 21
Implant Pain 19 19
Discomfort 18 18
Unspecified Mental, Emotional or Behavioural Problem 15 15
Chest Pain 14 14
Syncope/Fainting 13 13
Pain 12 12
Dysphagia/ Odynophagia 12 12
Anxiety 11 11
Paresis 11 11
No Known Impact Or Consequence To Patient 11 11
Headache 8 8
Hemorrhage/Bleeding 8 8
Arrhythmia 8 8
Tachycardia 7 7
Bradycardia 7 7
Unspecified Heart Problem 7 7
Insufficient Information 6 6
Vomiting 6 6
No Code Available 6 6
Shock from Patient Lead(s) 6 6
Nausea 6 6
Apnea 6 6
Inflammation 5 5
Heart Failure/Congestive Heart Failure 5 5
Cramp(s) /Muscle Spasm(s) 5 5
Low Blood Pressure/ Hypotension 5 5
Pocket Erosion 5 5
Ambulation Difficulties 5 5
Fibrosis 4 4
Unspecified Respiratory Problem 4 4
Pneumonia 4 4
Nerve Damage 4 4
Hypoesthesia 4 4
Wound Dehiscence 4 4
Unspecified Infection 4 4
Extreme Exhaustion 4 4
Dizziness 3 3
Aspiration/Inhalation 3 3
Muscle Weakness 3 3
Edema 3 3
Cardiac Arrest 3 3
Atrial Flutter 3 3

-
-