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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve
Product CodeETN
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLOTROPE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
CHECKPOINT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INOMED MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 314 314
2020 238 238
2021 194 194
2022 247 247
2023 390 390
2024 215 215

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 481 481
Incorrect, Inadequate or Imprecise Result or Readings 189 189
Device Sensing Problem 146 146
Failure to Sense 120 120
Unintended Deflation 86 86
Leak/Splash 72 72
Break 71 71
Unable to Obtain Readings 69 69
Obstruction of Flow 56 56
Adverse Event Without Identified Device or Use Problem 55 55
Noise, Audible 49 49
Inappropriate Audible Prompt/Feedback 45 45
False Negative Result 43 43
Sensing Intermittently 29 29
Inflation Problem 26 26
Connection Problem 25 25
Gas/Air Leak 25 25
False Positive Result 18 18
Failure to Power Up 18 18
Material Puncture/Hole 16 16
Partial Blockage 13 13
Computer Software Problem 13 13
Material Protrusion/Extrusion 12 12
Application Program Freezes, Becomes Nonfunctional 12 12
No Apparent Adverse Event 11 11
Intermittent Continuity 11 11
Fracture 10 10
Therapeutic or Diagnostic Output Failure 10 10
Intermittent Loss of Power 10 10
Circuit Failure 9 9
Blocked Connection 7 7
Deformation Due to Compressive Stress 6 6
Failure to Read Input Signal 5 5
Deflation Problem 5 5
Display or Visual Feedback Problem 5 5
Fluid/Blood Leak 5 5
Material Too Soft/Flexible 5 5
Material Split, Cut or Torn 5 5
Insufficient Information 5 5
Output Problem 4 4
Material Deformation 4 4
Electrical /Electronic Property Problem 4 4
Migration or Expulsion of Device 4 4
Signal Artifact/Noise 4 4
Detachment of Device or Device Component 4 4
Defective Device 4 4
Patient-Device Incompatibility 3 3
Material Separation 3 3
Loss of or Failure to Bond 3 3
Loose or Intermittent Connection 3 3
Physical Resistance/Sticking 3 3
Audible Prompt/Feedback Problem 3 3
Activation Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Twisted/Bent 2 2
Impedance Problem 2 2
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Complete Blockage 2 2
Erratic or Intermittent Display 2 2
Electromagnetic Interference 2 2
Shipping Damage or Problem 2 2
Defective Component 2 2
Failure to Unfold or Unwrap 2 2
Communication or Transmission Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Expulsion 2 2
Electrical Overstress 1 1
Electromagnetic Compatibility Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Battery Problem 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Failure to Cut 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Component Missing 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Defibrillation/Stimulation Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Display Difficult to Read 1 1
Corroded 1 1
Failure to Deliver Shock/Stimulation 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Energy Output Problem 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Failure to Run on Battery 1 1
Product Quality Problem 1 1
Increase in Pressure 1 1
Material Fragmentation 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Optical Problem 1 1
Activation Failure 1 1
Positioning Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 925 925
No Consequences Or Impact To Patient 395 395
Unintended Extubation 150 150
No Known Impact Or Consequence To Patient 69 69
Nerve Damage 56 56
Airway Obstruction 47 47
Low Oxygen Saturation 34 34
Unspecified Tissue Injury 22 22
Extubate 20 20
Paralysis 20 20
Insufficient Information 17 17
No Patient Involvement 15 15
Hemorrhage/Bleeding 9 9
Hypoxia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Foreign Body In Patient 8 8
Unspecified Respiratory Problem 7 7
Hypoventilation 7 7
Bradycardia 7 7
Bronchospasm 7 7
Injury 6 6
Burn(s) 6 6
Fatigue 5 5
Dyspnea 5 5
Low Blood Pressure/ Hypotension 5 5
Unspecified Infection 5 5
Obstruction/Occlusion 5 5
Swelling/ Edema 5 5
Cardiac Arrest 4 4
Cyanosis 3 3
Pneumothorax 3 3
Pain 3 3
Sore Throat 3 3
Brain Injury 3 3
Tachycardia 3 3
Respiratory Arrest 3 3
Paresthesia 2 2
Dysphasia 2 2
Mediastinal Shift 2 2
Discomfort 2 2
Perforation of Esophagus 2 2
Fungal Infection 2 2
Decreased Respiratory Rate 2 2
Needle Stick/Puncture 2 2
Radiation Exposure, Unintended 2 2
Sepsis 2 2
Paresis 2 2
Oversedation 2 2
Irritation 2 2
Ischemia 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Arrhythmia 2 2
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Anaphylactic Shock 1 1
Foreign Body Reaction 1 1
Headache 1 1
Non specific EKG/ECG Changes 1 1
Edema 1 1
Facial Nerve Paralysis 1 1
High Blood Pressure/ Hypertension 1 1
Laceration(s) 1 1
Nausea 1 1
Respiratory Distress 1 1
Increased Sensitivity 1 1
No Code Available 1 1
Cerebral Edema 1 1
Convulsion/Seizure 1 1
Diminished Pulse Pressure 1 1
Intraoperative Pain 1 1
Fluid Discharge 1 1
Choking 1 1
Skin Tears 1 1
Increased Peak Expiratory Flow rate 1 1
Deformity/ Disfigurement 1 1
Complaint, Ill-Defined 1 1
Blinking, Excessive 1 1
Rupture 1 1
Tissue Damage 1 1
Ulceration 1 1
Urinary Retention 1 1
Twitching 1 1
Dizziness 1 1
Cough 1 1
Pulmonary Hypertension 1 1
Partial thickness (Second Degree) Burn 1 1
Respiratory Insufficiency 1 1
Wheezing 1 1
Muscle/Tendon Damage 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Jan-10-2024
2 Medtronic Xomed, Inc. I Sep-01-2022
3 Medtronic Xomed, Inc. II Mar-10-2022
4 Neurovision Medical Products Inc II Aug-27-2020
5 Spes Medica II Jun-25-2021
6 Stryker Instruments Div. of Stryker Corporation II Oct-01-2019
7 The Magstim Company Limited II Jan-15-2021
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