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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcranial magnetic stimulator
Regulation Description Repetitive transcranial magnetic stimulation system.
Definition A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Product CodeOBP
Regulation Number 882.5805
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAIN ULTIMATE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BRAINSWAY , LTD.
  SUBSTANTIALLY EQUIVALENT 6
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAG & MORE GMBH
  SUBSTANTIALLY EQUIVALENT 3
MAGNUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 3
NEUROMODULATORY DEVICES & APPLICATIONS
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NEUROQORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REVITAL LAB, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEEMG, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE MAGSTIM COMPANY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
THE MAGSTIM COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 15 23
2022 59 59
2023 43 43
2024 50 50
2025 83 83
2026 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 77 78
Patient-Device Incompatibility 72 79
Insufficient Information 30 30
Patient Device Interaction Problem 21 21
Improper or Incorrect Procedure or Method 8 8
Appropriate Term/Code Not Available 6 6
Output Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Off-Label Use 2 2
Energy Output Problem 2 2
Use of Device Problem 2 2
Product Quality Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Unintended Electrical Shock 1 1
Wrong Label 1 1
Smoking 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defibrillation/Stimulation Problem 1 1
Unexpected Therapeutic Results 1 1
Human-Device Interface Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 72 72
Anxiety 57 64
Convulsion/Seizure 45 45
Tinnitus 43 43
Depression 42 49
Suicidal Ideation 35 42
Emotional Changes 34 41
Pain 31 38
Sleep Dysfunction 28 35
Cognitive Changes 28 28
Memory Loss/Impairment 27 27
Dizziness 21 21
Fatigue 15 22
Nausea 13 13
Brain Injury 11 11
Irritability 11 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Speech Disorder 10 10
Unspecified Mental, Emotional or Behavioural Problem 9 9
Vertigo 9 9
Twitching 9 9
Hearing Impairment 9 9
Confusion/ Disorientation 8 8
Balance Problems 6 6
Unspecified Eye / Vision Problem 6 6
Weight Changes 6 13
Ambulation Difficulties 5 5
Visual Impairment 5 5
Numbness 5 5
Eye Pain 4 4
Blurred Vision 4 11
Decreased Appetite 4 4
Tics/Tremor 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Discomfort 4 4
Hallucination 4 4
Unspecified Nervous System Problem 4 4
Increased Sensitivity 3 3
Lethargy 3 3
Hypersensitivity/Allergic reaction 3 3
Shaking/Tremors 3 3
Retinal Tear 3 3
High Blood Pressure/ Hypertension 3 3
Dysphasia 3 3
Visual Disturbances 3 3
Sensitivity of Teeth 2 2
Unspecified Heart Problem 2 2
Tachycardia 2 2
Bradycardia 2 2
Partial Hearing Loss 2 2

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