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 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
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 1
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 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 67 67
Insufficient Information 30 30
Patient-Device Incompatibility 22 22
Patient Device Interaction Problem 14 14
Improper or Incorrect Procedure or Method 5 5
Output Problem 4 4
Unintended Electrical Shock 2 2
Energy Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Product Quality Problem 2 2
Off-Label Use 1 1
Malposition of Device 1 1
Smoking 1 1
Output above Specifications 1 1
Use of Device Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defibrillation/Stimulation Problem 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
Anxiety 49 49
Headache 49 49
Tinnitus 36 36
Depression 31 31
Pain 30 30
Convulsion/Seizure 30 30
Suicidal Ideation 28 28
Sleep Dysfunction 26 26
Cognitive Changes 24 24
Emotional Changes 21 21
Memory Loss/Impairment 18 18
Dizziness 18 18
Fatigue 14 14
Nausea 11 11
Irritability 10 10
Twitching 9 9
Vertigo 8 8
Hearing Impairment 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Confusion/ Disorientation 7 7
Brain Injury 7 7
Weight Changes 6 6
Speech Disorder 6 6
Unspecified Mental, Emotional or Behavioural Problem 6 6
Unspecified Eye / Vision Problem 5 5
Seizures 5 5
Decreased Appetite 4 4
Increased Sensitivity 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Blurred Vision 4 4
Numbness 3 3
Balance Problems 3 3
Visual Impairment 3 3
Visual Disturbances 3 3
Loss of consciousness 3 3
Hypersensitivity/Allergic reaction 3 3
Lethargy 3 3
High Blood Pressure/ Hypertension 3 3
Retinal Tear 3 3
Dysphasia 3 3
Unspecified Heart Problem 2 2
Muscle Weakness 2 2
Myalgia 2 2
Movement Disorder 2 2
Skin Discoloration 2 2
Bradycardia 2 2
Sensitivity of Teeth 2 2
Ptosis 2 2
Hair Loss 2 2
Ambulation Difficulties 2 2

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