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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
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 1
BRAINSWAY LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 4
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NEUROQORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTIM PLC
  SUBSTANTIALLY EQUIVALENT 1
REMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
REVITAL LAB INC.
  SUBSTANTIALLY EQUIVALENT 1
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 12 12
2021 15 15
2022 59 59
2023 43 43
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 70 70
Insufficient Information 24 24
Patient-Device Incompatibility 23 23
Patient Device Interaction Problem 9 9
Improper or Incorrect Procedure or Method 5 5
Output Problem 4 4
Therapeutic or Diagnostic Output Failure 2 2
Unexpected Therapeutic Results 2 2
Energy Output Problem 2 2
Product Quality Problem 2 2
Defibrillation/Stimulation Problem 1 1
Smoking 1 1
Device Alarm System 1 1
Loose or Intermittent Connection 1 1
Output above Specifications 1 1
Loss of Power 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anxiety 52 52
Headache 48 48
Depression 35 35
Tinnitus 34 34
Pain 31 31
Cognitive Changes 27 27
Suicidal Ideation 27 27
Sleep Dysfunction 25 25
Convulsion/Seizure 24 24
Emotional Changes 21 21
Dizziness 19 19
Memory Loss/Impairment 16 16
Fatigue 13 13
Nausea 11 11
Twitching 10 10
Irritability 8 8
Confusion/ Disorientation 7 7
Brain Injury 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Vertigo 6 6
Hearing Impairment 6 6
Seizures 5 5
Unspecified Eye / Vision Problem 5 5
Unspecified Mental, Emotional or Behavioural Problem 5 5
Speech Disorder 5 5
Weight Changes 5 5
Cramp(s) /Muscle Spasm(s) 4 4
Increased Sensitivity 4 4
Hypersensitivity/Allergic reaction 4 4
High Blood Pressure/ Hypertension 3 3
Blurred Vision 3 3
Visual Impairment 3 3
Visual Disturbances 3 3
Numbness 3 3
Loss of consciousness 3 3
Palpitations 3 3
Decreased Appetite 3 3
Balance Problems 3 3
Lethargy 3 3
Therapeutic Response, Decreased 2 2
Patient Problem/Medical Problem 2 2
Ptosis 2 2
Unspecified Heart Problem 2 2
Movement Disorder 2 2
Shaking/Tremors 2 2
Sensitivity of Teeth 2 2
Myalgia 2 2
Undesired Nerve Stimulation 2 2
Tachycardia 2 2
Discomfort 2 2
Muscle Weakness 2 2
Skin Discoloration 2 2
Hearing Loss 2 2
Hair Loss 2 2
Diarrhea 2 2
Bradycardia 2 2
Calcium Deposits/Calcification 1 1
Death 1 1
Pulmonary Embolism 1 1
Syncope 1 1
Dry Eye(s) 1 1
Erythema 1 1
Fall 1 1
Head Injury 1 1
Vitreous Floaters 1 1
Hemorrhage/Bleeding 1 1
Intracranial Hemorrhage 1 1
Skin Irritation 1 1
Swelling 1 1
Paralysis 1 1
Loss of Range of Motion 1 1
Retinal Detachment 1 1
Nerve Damage 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Itching Sensation 1 1
Arthralgia 1 1
Malaise 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Dysphasia 1 1
Electrolyte Imbalance 1 1
Thrombosis 1 1
Vomiting 1 1
Sneezing 1 1
Disability 1 1
Inadequate Pain Relief 1 1
Neck Pain 1 1
Sweating 1 1
Diaphoresis 1 1
Electric Shock 1 1
Ambulation Difficulties 1 1
Neuralgia 1 1
Total Hearing Loss 1 1
Skin Inflammation/ Irritation 1 1
Eczema 1 1
Implant Pain 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Magstim Company Limited II May-13-2020
2 The Magstim Company Limited II Feb-14-2019
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