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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 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 478 478
Device Sensing Problem 146 146
Failure to Sense 120 120
Incorrect, Inadequate or Imprecise Result or Readings 115 115
Leak/Splash 72 72
Unable to Obtain Readings 69 69
Break 66 66
Adverse Event Without Identified Device or Use Problem 52 52
Noise, Audible 49 49
Unintended Deflation 43 43
Obstruction of Flow 42 42
Inappropriate Audible Prompt/Feedback 31 31
Sensing Intermittently 29 29
Inflation Problem 26 26
Gas/Air Leak 25 25
Connection Problem 25 25
Material Puncture/Hole 16 16
False Negative Result 16 16
False Positive Result 15 15
Partial Blockage 13 13
Failure to Power Up 12 12
Intermittent Continuity 11 11
No Apparent Adverse Event 11 11
Material Protrusion/Extrusion 10 10
Therapeutic or Diagnostic Output Failure 10 10
Intermittent Loss of Power 10 10
Fracture 10 10
Application Program Freezes, Becomes Nonfunctional 8 8
Computer Software Problem 7 7
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 Split, Cut or Torn 5 5
Insufficient Information 5 5
Material Too Soft/Flexible 4 4
Output Problem 4 4
Electrical /Electronic Property Problem 4 4
Migration or Expulsion of Device 4 4
Circuit Failure 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
Signal Artifact/Noise 3 3
Loose or Intermittent Connection 3 3
Material Deformation 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
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Erratic or Intermittent Display 2 2
Electromagnetic Interference 2 2
Complete Blockage 2 2
Shipping Damage or Problem 2 2
Defective Component 2 2
Communication or Transmission Problem 2 2
Impedance Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Expulsion 2 2
Electrical Overstress 1 1
Electromagnetic Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Battery Problem 1 1
Device Displays Incorrect Message 1 1
Component Missing 1 1
Expiration Date Error 1 1
Failure to Cut 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
Defibrillation/Stimulation Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Contamination 1 1
Burst Container or Vessel 1 1
Display Difficult to Read 1 1
Corroded 1 1
Failure to Deliver Shock/Stimulation 1 1
Energy Output Problem 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Failure to Run on Battery 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Optical Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Ventilation Problem in Device Environment 1 1
Activation Failure 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Illegible Information 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 771 771
No Consequences Or Impact To Patient 395 395
Unintended Extubation 125 125
No Known Impact Or Consequence To Patient 69 69
Nerve Damage 49 49
Airway Obstruction 46 46
Low Oxygen Saturation 31 31
Extubate 20 20
Paralysis 20 20
Unspecified Tissue Injury 19 19
Insufficient Information 16 16
No Patient Involvement 15 15
Bronchospasm 7 7
Hypoventilation 7 7
Hemorrhage/Bleeding 7 7
Unspecified Respiratory Problem 7 7
Foreign Body In Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Burn(s) 6 6
Bradycardia 6 6
Injury 6 6
Obstruction/Occlusion 5 5
Fatigue 5 5
Hypoxia 5 5
Unspecified Infection 5 5
Swelling/ Edema 5 5
Low Blood Pressure/ Hypotension 4 4
Pain 3 3
Tachycardia 3 3
Cardiac Arrest 3 3
Cyanosis 3 3
Dyspnea 3 3
Sore Throat 3 3
Brain Injury 3 3
Discomfort 2 2
Dysphasia 2 2
Needle Stick/Puncture 2 2
Fungal Infection 2 2
Radiation Exposure, Unintended 2 2
Paresthesia 2 2
Respiratory Arrest 2 2
Hypersensitivity/Allergic reaction 2 2
Apnea 2 2
Arrhythmia 2 2
Paresis 2 2
Pneumothorax 2 2
Oversedation 2 2
Irritation 2 2
Laceration(s) 1 1
Nausea 1 1
Respiratory Distress 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Tissue Damage 1 1
Ulceration 1 1
Urinary Retention 1 1
Twitching 1 1
Dizziness 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Bruise/Contusion 1 1
Anaphylactic Shock 1 1
High Blood Pressure/ Hypertension 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
Wheezing 1 1
Cough 1 1
Pulmonary Hypertension 1 1
No Code Available 1 1
Cerebral Edema 1 1
Convulsion/Seizure 1 1
Diminished Pulse Pressure 1 1
Skin Tears 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
Choking 1 1
Perforation of Esophagus 1 1
Deformity/ Disfigurement 1 1
Mediastinal Shift 1 1
Rupture 1 1
Complaint, Ill-Defined 1 1
Blinking, Excessive 1 1
Unintended Radiation Exposure 1 1
Muscle/Tendon Damage 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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