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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 1
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 117 117
2018 250 250
2019 314 314
2020 238 238
2021 195 195
2022 206 206

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 492 492
Failure to Sense 146 146
Device Sensing Problem 134 134
Unable to Obtain Readings 71 71
Adverse Event Without Identified Device or Use Problem 68 68
Device Operates Differently Than Expected 63 63
Break 63 63
Leak/Splash 47 47
Noise, Audible 44 44
Sensing Intermittently 42 42
Inflation Problem 32 32
False Negative Result 24 24
Connection Problem 20 20
Material Puncture/Hole 19 19
Intermittent Continuity 16 16
Gas/Air Leak 16 16
False Positive Result 15 15
Partial Blockage 14 14
Air Leak 13 13
Obstruction of Flow 13 13
Appropriate Term/Code Not Available 12 12
No Apparent Adverse Event 10 10
Deflation Problem 10 10
Device Stops Intermittently 9 9
Therapeutic or Diagnostic Output Failure 9 9
Failure to Read Input Signal 8 8
Occlusion Within Device 8 8
Electrical /Electronic Property Problem 8 8
Fracture 8 8
Insufficient Information 7 7
Defective Device 6 6
Blocked Connection 5 5
Output Problem 5 5
Material Deformation 5 5
Intermittent Loss of Power 5 5
Audible Prompt/Feedback Problem 5 5
Loose or Intermittent Connection 5 5
Display or Visual Feedback Problem 5 5
Signal Artifact/Noise 4 4
Fluid/Blood Leak 4 4
Mechanical Problem 4 4
Failure to Power Up 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Material Too Soft/Flexible 4 4
Material Protrusion/Extrusion 4 4
Deformation Due to Compressive Stress 4 4
Positioning Problem 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 3 3
No Device Output 3 3
Material Separation 3 3
Fitting Problem 3 3
Migration or Expulsion of Device 3 3
Hole In Material 3 3
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Failure to Deliver Energy 2 2
No Display/Image 2 2
Electromagnetic Interference 2 2
Device Alarm System 2 2
Complete Blockage 2 2
Shipping Damage or Problem 2 2
Self-Activation or Keying 2 2
Failure to Transmit Record 2 2
Difficult to Remove 2 2
Erratic Results 2 2
Electrical Shorting 2 2
Material Twisted/Bent 2 2
Impedance Problem 2 2
Communication or Transmission Problem 2 2
Device Displays Incorrect Message 2 2
Detachment of Device or Device Component 2 2
Defective Component 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Dislodged or Dislocated 1 1
Component Missing 1 1
Failure to Fire 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Computer Operating System Problem 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Mechanical Jam 1 1
Electromagnetic Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Optical Problem 1 1
Scratched Material 1 1
Device Contaminated at the User Facility 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Illegible Information 1 1
Missing Information 1 1
Complete Loss of Power 1 1
Wireless Communication Problem 1 1
Patient Device Interaction Problem 1 1
Migration 1 1
Product Quality Problem 1 1
Failure to Analyze Signal 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 583 583
No Clinical Signs, Symptoms or Conditions 363 363
No Known Impact Or Consequence To Patient 158 158
Extubate 64 64
Nerve Damage 46 46
Unintended Extubation 44 44
No Patient Involvement 33 33
Airway Obstruction 31 31
Paralysis 22 22
Low Oxygen Saturation 22 22
Insufficient Information 15 15
Injury 11 11
Facial Nerve Paralysis 11 11
Paresis 9 9
Unspecified Tissue Injury 9 9
Bronchospasm 8 8
Burn(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Fatigue 5 5
Dyspnea 5 5
Hypoxia 5 5
Unspecified Infection 5 5
Respiratory Distress 4 4
Occlusion 3 3
Low Blood Pressure/ Hypotension 3 3
Edema 3 3
Bradycardia 3 3
Obstruction/Occlusion 3 3
Foreign Body In Patient 3 3
Nervous System Injury 2 2
Radiation Exposure, Unintended 2 2
Needle Stick/Puncture 2 2
Fungal Infection 2 2
Skin Tears 2 2
Dysphasia 2 2
Mediastinal Shift 2 2
Rupture 2 2
Tissue Damage 2 2
Cardiac Arrest 2 2
Arrhythmia 2 2
Hemorrhage/Bleeding 2 2
Hypoventilation 2 2
Irritation 2 2
Oversedation 2 2
Pain 2 2
Pneumothorax 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
Unintended Radiation Exposure 1 1
Swelling/ Edema 1 1
Seizures 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Foreign Body Reaction 1 1
Headache 1 1
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Apnea 1 1
Bruise/Contusion 1 1
Ulceration 1 1
Urinary Retention 1 1
Twitching 1 1
Dizziness 1 1
Brain Injury 1 1
Blinking, Excessive 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Coma 1 1
Sore Throat 1 1
Laceration(s) of Esophagus 1 1
Perforation of Esophagus 1 1
Respiratory Acidosis 1 1
Abnormal Blood Gases 1 1
Device Embedded In Tissue or Plaque 1 1
Partial thickness (Second Degree) Burn 1 1
Decreased Sensitivity 1 1
Fluid Discharge 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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