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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, evoked response
Product CodeGWF
Regulation Number 882.1870
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CAREFUSION 209, INC.
  SUBSTANTIALLY EQUIVALENT 2
EB NEURO, S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
INOMED MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 3
LABORIE MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
NATUS NEUROLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NEUROSOFT LTD
  SUBSTANTIALLY EQUIVALENT 1
NEUROVISION MEDICAL PRODUCT INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXSTIM OY
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SAFEOP SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STROHL MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 25 25
2015 22 22
2016 20 20
2017 60 60
2018 58 58
2019 94 94
2020 65 65
2021 54 54
2022 45 45
2023 150 150
2024 421 421

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 270 270
Use of Device Problem 262 262
Failure to Power Up 82 82
Inappropriate Audible Prompt/Feedback 62 62
Device Operates Differently Than Expected 58 58
False Negative Result 56 56
False Positive Result 43 43
Computer Software Problem 40 40
Unable to Obtain Readings 24 24
Break 24 24
Device Sensing Problem 24 24
Connection Problem 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Signal Artifact/Noise 19 19
Mechanical Problem 19 19
Output Problem 18 18
Sensing Intermittently 15 15
Failure to Sense 15 15
Problem with Software Installation 14 14
Application Program Problem 14 14
Application Program Freezes, Becomes Nonfunctional 11 11
Failure to Deliver Energy 10 10
Communication or Transmission Problem 10 10
Device Stops Intermittently 10 10
Electrical /Electronic Property Problem 10 10
Disconnection 9 9
Unintended Application Program Shut Down 9 9
Insufficient Information 9 9
Inappropriate/Inadequate Shock/Stimulation 8 8
Noise, Audible 8 8
Energy Output Problem 7 7
Device Displays Incorrect Message 7 7
Appropriate Term/Code Not Available 7 7
Intermittent Continuity 7 7
Loose or Intermittent Connection 6 6
Display or Visual Feedback Problem 6 6
Battery Problem 6 6
Incomplete or Inadequate Connection 6 6
Overheating of Device 6 6
Circuit Failure 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Unexpected Shutdown 5 5
Detachment of Device or Device Component 4 4
Temperature Problem 4 4
Impedance Problem 3 3
Audible Prompt/Feedback Problem 3 3
Defective Component 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Fitting Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 670 670
No Consequences Or Impact To Patient 196 196
No Known Impact Or Consequence To Patient 106 106
Nerve Damage 19 19
No Patient Involvement 16 16
No Information 10 10
Burn(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Not Applicable 3 3
Hemorrhage/Bleeding 3 3
Paralysis 3 3
Insufficient Information 3 3
Sedation 3 3
Electric Shock 2 2
Unintended Extubation 2 2
Lead(s), Burn(s) From 2 2
Loss of consciousness 2 2
Facial Nerve Paralysis 2 2
Convulsion/Seizure 2 2
Tachycardia 2 2
Burning Sensation 2 2
Injury 2 2
Numbness 2 2
Device Embedded In Tissue or Plaque 1 1
Ambulation Difficulties 1 1
Low Oxygen Saturation 1 1
Paraplegia 1 1
Partial thickness (Second Degree) Burn 1 1
Tissue Damage 1 1
Unspecified Tissue Injury 1 1
Bronchospasm 1 1
Stenosis 1 1
Muscle/Tendon Damage 1 1
Paresis 1 1
Pain 1 1
Laceration(s) 1 1
Depression 1 1
Twitching 1 1
Muscular Rigidity 1 1
Confusion/ Disorientation 1 1
Neurological Deficit/Dysfunction 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Abrasion 1 1
Muscle Weakness 1 1
Dizziness 1 1
No Code Available 1 1
Radiation Exposure, Unintended 1 1
Diaphoresis 1 1
Brain Injury 1 1
Skin Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alpine Biomed Aps II May-25-2013
2 Cadwell Industries Inc II Jul-12-2024
3 Cadwell Industries Inc II May-22-2024
4 Medtronic Xomed, Inc. I Jul-24-2024
5 Medtronic Xomed, Inc. II Jun-02-2022
6 Medtronic Xomed, Inc. II Sep-10-2012
7 Natus Medical Incorporated II Feb-09-2015
8 Nexstim PLC II May-22-2017
9 Nihon Kohden America Inc II Feb-17-2016
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