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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 4
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MAG & MORE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAGNUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEUROMODULATORY DEVICES & APPLICATIONS
  SUBSTANTIALLY EQUIVALENT 1
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEUROQORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
REVITAL LAB INC.
  SUBSTANTIALLY EQUIVALENT 1
THE MAGSTIM COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 12 12
2021 15 15
2022 59 59
2023 43 43
2024 49 49
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 73 73
Insufficient Information 31 31
Patient-Device Incompatibility 27 27
Patient Device Interaction Problem 17 17
Improper or Incorrect Procedure or Method 6 6
Output Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Unintended Electrical Shock 2 2
Energy Output Problem 2 2
Product Quality Problem 2 2
Off-Label Use 1 1
Malposition of Device 1 1
Wrong Label 1 1
Smoking 1 1
Output above Specifications 1 1
Use of Device Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Appropriate Term/Code Not Available 1 1
Unexpected Therapeutic Results 1 1
Loose or Intermittent Connection 1 1
Device Displays Incorrect Message 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 53 53
Anxiety 51 51
Tinnitus 38 38
Convulsion/Seizure 34 34
Pain 32 32
Depression 31 31
Suicidal Ideation 28 28
Sleep Dysfunction 26 26
Cognitive Changes 25 25
Emotional Changes 23 23
Dizziness 20 20
Memory Loss/Impairment 20 20
Fatigue 14 14
Irritability 11 11
Nausea 11 11
Twitching 10 10
Brain Injury 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Mental, Emotional or Behavioural Problem 8 8
Hearing Impairment 8 8
Vertigo 8 8
Confusion/ Disorientation 7 7
Speech Disorder 7 7
Weight Changes 6 6
Unspecified Eye / Vision Problem 5 5
Seizures 5 5
Blurred Vision 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Balance Problems 4 4
Increased Sensitivity 4 4
Decreased Appetite 4 4
Ambulation Difficulties 4 4
Numbness 3 3
Hypersensitivity/Allergic reaction 3 3
Loss of consciousness 3 3
Lethargy 3 3
Visual Impairment 3 3
Retinal Tear 3 3
High Blood Pressure/ Hypertension 3 3
Visual Disturbances 3 3
Dysphasia 3 3
Discomfort 3 3
Hair Loss 2 2
Ptosis 2 2
Diarrhea 2 2
Bradycardia 2 2
Skin Discoloration 2 2
Movement Disorder 2 2
Myalgia 2 2
Unspecified Heart Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 The Magstim Company Limited II May-13-2020
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