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 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
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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 69 69
Patient-Device Incompatibility 23 23
Insufficient Information 22 22
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 47 47
Headache 44 44
Tinnitus 34 34
Depression 30 30
Pain 27 27
Suicidal Ideation 26 26
Cognitive Changes 24 24
Convulsion/Seizure 23 23
Sleep Dysfunction 22 22
Emotional Changes 20 20
Dizziness 19 19
Memory Loss/Impairment 13 13
Nausea 11 11
Fatigue 11 11
Twitching 10 10
Irritability 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Confusion/ Disorientation 6 6
Vertigo 6 6
Hearing Impairment 5 5
Seizures 5 5
Weight Changes 5 5
Unspecified Eye / Vision Problem 5 5
Speech Disorder 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
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
Brain Injury 3 3
Lethargy 3 3
Palpitations 3 3
Numbness 3 3
Loss of consciousness 3 3
Decreased Appetite 3 3
Balance Problems 3 3
Unspecified Heart Problem 2 2
Ptosis 2 2
Movement Disorder 2 2
Patient Problem/Medical Problem 2 2
Sensitivity of Teeth 2 2
Shaking/Tremors 2 2
Therapeutic Response, Decreased 2 2
Myalgia 2 2
Discomfort 2 2
Undesired Nerve Stimulation 2 2
Hearing Loss 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
Hemorrhage/Bleeding 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
Dysphasia 1 1
Electrolyte Imbalance 1 1
Vomiting 1 1
Arthralgia 1 1
Malaise 1 1
Sneezing 1 1
Convulsion, Clonic 1 1
Convulsion, Tonic 1 1
Electric Shock 1 1
Ambulation Difficulties 1 1
Neck Pain 1 1
Sweating 1 1
Diaphoresis 1 1
Disability 1 1
Inadequate Pain Relief 1 1
No Information 1 1
Neuralgia 1 1
Vaso-Vagal Response 1 1
Superficial (First Degree) Burn 1 1
Eye Pain 1 1
Paresthesia 1 1
Bruxism 1 1
Total Hearing Loss 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
-
-