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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 1

MDR Year MDR Reports MDR Events
2018 250 250
2019 314 314
2020 238 238
2021 195 195
2022 249 249
2023 97 97

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 527 527
Device Sensing Problem 152 152
Failure to Sense 149 149
Unable to Obtain Readings 90 90
Break 66 66
Leak/Splash 64 64
Adverse Event Without Identified Device or Use Problem 63 63
Noise, Audible 50 50
Sensing Intermittently 37 37
Inflation Problem 32 32
Device Operates Differently Than Expected 30 30
Connection Problem 23 23
Gas/Air Leak 20 20
Obstruction of Flow 20 20
Material Puncture/Hole 16 16
False Positive Result 16 16
Partial Blockage 15 15
Intermittent Continuity 15 15
Appropriate Term/Code Not Available 11 11
Therapeutic or Diagnostic Output Failure 10 10
No Apparent Adverse Event 10 10
Fracture 10 10
Intermittent Loss of Power 9 9
Electrical /Electronic Property Problem 8 8
Deflation Problem 8 8
Failure to Read Input Signal 8 8
Insufficient Information 7 7
Defective Device 6 6
Device Stops Intermittently 6 6
Display or Visual Feedback Problem 6 6
False Negative Result 6 6
Occlusion Within Device 6 6
Loose or Intermittent Connection 5 5
Blocked Connection 5 5
Deformation Due to Compressive Stress 5 5
Material Deformation 5 5
Material Protrusion/Extrusion 5 5
Output Problem 5 5
Audible Prompt/Feedback Problem 5 5
Material Too Soft/Flexible 4 4
Mechanical Problem 4 4
Migration or Expulsion of Device 4 4
Signal Artifact/Noise 4 4
Fluid/Blood Leak 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Material Separation 3 3
Failure to Power Up 3 3
Fitting Problem 3 3
Air Leak 3 3
Complete Blockage 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
Positioning Problem 3 3
Detachment of Device or Device Component 3 3
Defective Component 2 2
Communication or Transmission Problem 2 2
Device Displays Incorrect Message 2 2
Material Twisted/Bent 2 2
Tear, Rip or Hole in Device Packaging 2 2
Impedance Problem 2 2
Erratic Results 2 2
Electromagnetic Interference 2 2
Failure to Deliver Energy 2 2
Delivered as Unsterile Product 2 2
Self-Activation or Keying 2 2
No Device Output 2 2
Shipping Damage or Problem 2 2
Defibrillation/Stimulation Problem 1 1
Failure to Analyze Signal 1 1
Failure to Transmit Record 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Failure to Run on Battery 1 1
Product Quality Problem 1 1
Failure to Select Signal 1 1
Sticking 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
No Audible Prompt/Feedback 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Device Damaged Prior to Use 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Failure to Cut 1 1
Energy Output Problem 1 1
Hole In Material 1 1
Computer Software Problem 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Loss of or Failure to Bond 1 1
Disconnection 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
Corroded 1 1
Failure to Deliver Shock/Stimulation 1 1
Crack 1 1
Unintended Deflation 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 523 523
No Clinical Signs, Symptoms or Conditions 477 477
No Known Impact Or Consequence To Patient 135 135
Unintended Extubation 66 66
Nerve Damage 47 47
Extubate 44 44
Airway Obstruction 37 37
No Patient Involvement 33 33
Low Oxygen Saturation 25 25
Paralysis 23 23
Insufficient Information 15 15
Injury 11 11
Unspecified Tissue Injury 10 10
Paresis 9 9
Bronchospasm 7 7
Foreign Body In Patient 6 6
Burn(s) 6 6
Facial Nerve Paralysis 6 6
Hypoxia 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unspecified Infection 5 5
Hypoventilation 5 5
Fatigue 5 5
Dyspnea 5 5
Obstruction/Occlusion 4 4
Pain 3 3
Occlusion 3 3
Cardiac Arrest 3 3
Bradycardia 3 3
Low Blood Pressure/ Hypotension 3 3
Respiratory Distress 3 3
Edema 2 2
Irritation 2 2
Apnea 2 2
Arrhythmia 2 2
Oversedation 2 2
Pneumothorax 2 2
Dysphasia 2 2
Brain Injury 2 2
Fungal Infection 2 2
Needle Stick/Puncture 2 2
Nervous System Injury 2 2
Skin Tears 2 2
Radiation Exposure, Unintended 2 2
No Information 2 2
No Code Available 2 2
Paresthesia 2 2
Cough 1 1
Pulmonary Hypertension 1 1
Respiratory Arrest 1 1
Missing Value Reason 1 1
Cerebral Edema 1 1
Convulsion/Seizure 1 1
Partial thickness (Second Degree) Burn 1 1
Unintended Radiation Exposure 1 1
Swelling/ Edema 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Diminished Pulse Pressure 1 1
Respiratory Acidosis 1 1
Coma 1 1
Rupture 1 1
Blinking, Excessive 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Deformity/ Disfigurement 1 1
Sore Throat 1 1
Perforation of Esophagus 1 1
Mediastinal Shift 1 1
Neurological Deficit/Dysfunction 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Anaphylactic Shock 1 1
Non specific EKG/ECG Changes 1 1
Foreign Body Reaction 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Nausea 1 1
Abnormal Blood Gases 1 1
Seizures 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Tachycardia 1 1
Tissue Damage 1 1
Ulceration 1 1
Urinary Retention 1 1
Twitching 1 1
Dizziness 1 1

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