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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 4
BRAINSWAY, LTD
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MAG & MORE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAGNUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY LTD
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 7
NEURONETICS
  SUBSTANTIALLY EQUIVALENT 4
NEURONETICS, INC
  SUBSTANTIALLY EQUIVALENT 2
NEURONETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
NEUROQORE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTIM PLC
  SUBSTANTIALLY EQUIVALENT 2
REMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
REVITAL LAB INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEEMG, LLC
  SUBSTANTIALLY EQUIVALENT 2
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2015 3 3
2016 6 6
2017 3 3
2018 6 6
2019 12 12
2020 12 12
2021 15 15
2022 59 59
2023 43 43
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 77 77
Insufficient Information 27 27
Patient-Device Incompatibility 24 24
Patient Device Interaction Problem 9 9
Improper or Incorrect Procedure or Method 6 6
Output Problem 4 4
Unexpected Therapeutic Results 3 3
Therapeutic or Diagnostic Output Failure 2 2
Device Operates Differently Than Expected 2 2
Energy Output Problem 2 2
Product Quality Problem 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Unintended Electrical Shock 1 1
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
Inadequate Instructions for Non-Healthcare Professional 1 1
Use of Device Problem 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anxiety 52 52
Headache 47 47
Depression 38 38
Tinnitus 35 35
Pain 32 32
Sleep Dysfunction 27 27
Suicidal Ideation 26 26
Cognitive Changes 24 24
Emotional Changes 24 24
Convulsion/Seizure 23 23
Dizziness 20 20
Memory Loss/Impairment 14 14
Nausea 13 13
Fatigue 11 11
Twitching 10 10
Irritability 9 9
Seizures 8 8
Confusion/ Disorientation 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Weight Changes 6 6
Hearing Impairment 6 6
Vertigo 6 6
Loss of consciousness 5 5
Unspecified Eye / Vision Problem 5 5
Speech Disorder 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Increased Sensitivity 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Complaint, Ill-Defined 4 4
Hypersensitivity/Allergic reaction 4 4
High Blood Pressure/ Hypertension 3 3
Brain Injury 3 3
Blurred Vision 3 3
Visual Impairment 3 3
Visual Disturbances 3 3
Ambulation Difficulties 3 3
Palpitations 3 3
Therapeutic Response, Decreased 3 3
Numbness 3 3
Lethargy 3 3
Decreased Appetite 3 3
Balance Problems 3 3
Ptosis 2 2
Unspecified Heart Problem 2 2
Movement Disorder 2 2
Patient Problem/Medical Problem 2 2
Inadequate Pain Relief 2 2
Discomfort 2 2
Shaking/Tremors 2 2
Sensitivity of Teeth 2 2
Vomiting 2 2
Undesired Nerve Stimulation 2 2
Myalgia 2 2
Hearing Loss 2 2
Hemorrhage/Bleeding 2 2
Skin Discoloration 2 2
Tachycardia 2 2
Muscle Weakness 2 2
Erythema 1 1
Fall 1 1
Paralysis 1 1
Loss of Range of Motion 1 1
Retinal Detachment 1 1
Thrombosis 1 1
Nerve Damage 1 1
Skin Irritation 1 1
Swelling 1 1
Intracranial Hemorrhage 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Inflammation 1 1
Itching Sensation 1 1
Vitreous Floaters 1 1
Hair Loss 1 1
Head Injury 1 1
Pulmonary Embolism 1 1
Syncope 1 1
Calcium Deposits/Calcification 1 1
Death 1 1
Diarrhea 1 1
Dry Eye(s) 1 1
Sneezing 1 1
Stenosis 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Injury 1 1
Arthralgia 1 1
Malaise 1 1
Dysphasia 1 1
Electrolyte Imbalance 1 1
Weakness 1 1
Neck Pain 1 1
Sweating 1 1
Diaphoresis 1 1
Disability 1 1
Reaction 1 1
No Information 1 1
No Code Available 1 1
Neuralgia 1 1
Eye Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Neuronetics, Inc. II May-27-2009
2 The Magstim Company Limited II May-13-2020
3 The Magstim Company Limited II Feb-14-2019
4 The Magstim Company Limited II Apr-11-2018
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