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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 337 337

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 484 484
Incorrect, Inadequate or Imprecise Result or Readings 243 243
Device Sensing Problem 146 146
Failure to Sense 120 120
Unintended Deflation 108 108
Break 74 74
Leak/Splash 72 72
Unable to Obtain Readings 69 69
Inappropriate Audible Prompt/Feedback 60 60
Obstruction of Flow 60 60
Adverse Event Without Identified Device or Use Problem 55 55
False Negative Result 53 53
Noise, Audible 49 49
Sensing Intermittently 29 29
Inflation Problem 28 28
Connection Problem 26 26
Gas/Air Leak 25 25
Failure to Power Up 22 22
False Positive Result 20 20
Material Puncture/Hole 16 16
Computer Software Problem 15 15
Partial Blockage 13 13
Circuit Failure 12 12
Material Protrusion/Extrusion 12 12
Application Program Freezes, Becomes Nonfunctional 12 12
No Apparent Adverse Event 11 11
Intermittent Continuity 11 11
Fracture 11 11
Intermittent Loss of Power 10 10
Therapeutic or Diagnostic Output Failure 10 10
Material Too Soft/Flexible 7 7
Blocked Connection 7 7
Deformation Due to Compressive Stress 6 6
Defective Device 5 5
Failure to Read Input Signal 5 5
Fluid/Blood Leak 5 5
Deflation Problem 5 5
Signal Artifact/Noise 5 5
Display or Visual Feedback Problem 5 5
Material Split, Cut or Torn 5 5
Insufficient Information 5 5
Failure to Deflate 5 5
Output Problem 4 4
Material Deformation 4 4
Migration or Expulsion of Device 4 4
Electrical /Electronic Property Problem 4 4
Detachment of Device or Device Component 4 4
Patient-Device Incompatibility 3 3
Tear, Rip or Hole in Device Packaging 3 3
Material Separation 3 3
Loose or Intermittent Connection 3 3
Loss of or Failure to Bond 3 3
Material Twisted/Bent 3 3
Physical Resistance/Sticking 3 3
Audible Prompt/Feedback Problem 3 3
Activation Problem 2 2
Appropriate Term/Code Not Available 2 2
Expulsion 2 2
Impedance Problem 2 2
Complete Blockage 2 2
Electromagnetic Interference 2 2
Erratic or Intermittent Display 2 2
Mechanical Problem 2 2
Delivered as Unsterile Product 2 2
Shipping Damage or Problem 2 2
Failure to Unfold or Unwrap 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Communication or Transmission Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Battery Problem 1 1
Device Displays Incorrect Message 1 1
Malposition of Device 1 1
Component Missing 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Failure to Cut 1 1
Defibrillation/Stimulation Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Material Perforation 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
Difficult to Insert 1 1
Material Fragmentation 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
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Electrical Overstress 1 1
Electromagnetic Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1032 1032
No Consequences Or Impact To Patient 395 395
Unintended Extubation 171 171
No Known Impact Or Consequence To Patient 69 69
Nerve Damage 57 57
Airway Obstruction 51 51
Low Oxygen Saturation 36 36
Unspecified Tissue Injury 22 22
Extubate 20 20
Paralysis 20 20
Insufficient Information 18 18
No Patient Involvement 15 15
Hemorrhage/Bleeding 10 10
Hypoventilation 10 10
Foreign Body In Patient 9 9
Hypoxia 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Respiratory Problem 7 7
Bradycardia 7 7
Bronchospasm 7 7
Injury 6 6
Burn(s) 6 6
Fatigue 5 5
Dyspnea 5 5
Unspecified Infection 5 5
Low Blood Pressure/ Hypotension 5 5
Obstruction/Occlusion 5 5
Swelling/ Edema 5 5
Scar Tissue 4 4
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
Radiation Exposure, Unintended 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
Sepsis 2 2
Paresis 2 2
Irritation 2 2
Ischemia 2 2
Laceration(s) 2 2
Hypersensitivity/Allergic reaction 2 2
Oversedation 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
Nausea 1 1
Respiratory Distress 1 1
Increased Sensitivity 1 1
Partial thickness (Second Degree) Burn 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
No Code Available 1 1
Cerebral Edema 1 1
Convulsion/Seizure 1 1
Cough 1 1
Pulmonary Hypertension 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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