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TPLC
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Device
stimulator, nerve
Product Code
ETN
Regulation Number
874.1820
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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