• 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 stimulator, electrical, evoked response
Regulation Description Evoked response electrical stimulator.
Product CodeGWF
Regulation Number 882.1870
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CADWELL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOMED MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATUS NEUROLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
NEUROSOFT LTD
  SUBSTANTIALLY EQUIVALENT 1
QUANTALX NEUROSCIENCE
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 65 65
2021 54 54
2022 45 45
2023 150 150
2024 854 854
2025 528 528

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 843 843
Use of Device Problem 254 254
Inappropriate Audible Prompt/Feedback 174 174
False Negative Result 160 160
Failure to Power Up 112 112
False Positive Result 88 88
Computer Software Problem 66 66
Unable to Obtain Readings 54 54
Problem with Software Installation 42 42
Connection Problem 38 38
Application Program Freezes, Becomes Nonfunctional 33 33
Break 33 33
Incomplete or Inadequate Connection 33 33
Device Sensing Problem 28 28
Battery Problem 25 25
Signal Artifact/Noise 23 23
Electrical /Electronic Property Problem 20 20
Unintended Application Program Shut Down 18 18
Output Problem 15 15
Failure to Sense 12 12
Application Program Problem 10 10
Communication or Transmission Problem 10 10
No Device Output 10 10
Sensing Intermittently 10 10
Display or Visual Feedback Problem 9 9
Loose or Intermittent Connection 7 7
Temperature Problem 7 7
Noise, Audible 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Device Misassembled During Manufacturing /Shipping 6 6
Energy Output Problem 5 5
Intermittent Continuity 5 5
Unexpected Shutdown 5 5
Fitting Problem 5 5
Failure to Deliver Energy 5 5
Therapeutic or Diagnostic Output Failure 3 3
Intermittent Loss of Power 3 3
Failure to Deliver Shock/Stimulation 2 2
Overheating of Device 2 2
Failure of Device to Self-Test 2 2
No Apparent Adverse Event 2 2
Defibrillation/Stimulation Problem 2 2
Material Deformation 2 2
Device Fell 2 2
Wireless Communication Problem 2 2
Device Alarm System 2 2
Low Readings 1 1
Audible Prompt/Feedback Problem 1 1
Electrical Shorting 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1565 1565
No Consequences Or Impact To Patient 48 48
Insufficient Information 36 36
Nerve Damage 21 21
Superficial (First Degree) Burn 13 13
No Known Impact Or Consequence To Patient 5 5
Burn(s) 5 5
Paralysis 4 4
Paresis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Numbness 3 3
Unintended Extubation 3 3
Convulsion/Seizure 2 2
Loss of consciousness 2 2
Hemorrhage/Bleeding 2 2
Dysphasia 1 1
Electric Shock 1 1
Speech Disorder 1 1
Brain Injury 1 1
Fatigue 1 1
Diaphoresis 1 1
Dizziness 1 1
Muscle Weakness 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Confusion/ Disorientation 1 1
Unspecified Nervous System Problem 1 1
No Patient Involvement 1 1
Twitching 1 1
Muscular Rigidity 1 1
Laceration(s) 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Tachycardia 1 1
Stenosis 1 1
Ambulation Difficulties 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cadwell Industries Inc II Jul-12-2024
2 Cadwell Industries Inc II May-22-2024
3 Medtronic Xomed, Inc. II Apr-18-2025
4 Medtronic Xomed, Inc. I Jul-24-2024
5 Medtronic Xomed, Inc. II Jun-02-2022
-
-