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TPLC
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Device
stimulator, electrical, evoked response
Regulation Description
Evoked response electrical stimulator.
Product Code
GWF
Regulation Number
882.1870
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALPHATEC SPINE, INC.
SUBSTANTIALLY EQUIVALENT
2
CADWELL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
INOMED MEDIZINTECHNIK GMBH
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC XOMED, INC.
SUBSTANTIALLY EQUIVALENT
1
NATUS NEUROLOGY INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
NEUROSOFT LTD
SUBSTANTIALLY EQUIVALENT
1
QUANTALX NEUROSCIENCE
SUBSTANTIALLY EQUIVALENT
1
SOTERIX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
65
65
2021
54
54
2022
45
45
2023
150
150
2024
854
854
2025
528
528
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
843
843
Use of Device Problem
254
254
Inappropriate Audible Prompt/Feedback
174
174
False Negative Result
160
160
Failure to Power Up
112
112
False Positive Result
88
88
Computer Software Problem
66
66
Unable to Obtain Readings
54
54
Problem with Software Installation
42
42
Connection Problem
38
38
Application Program Freezes, Becomes Nonfunctional
33
33
Break
33
33
Incomplete or Inadequate Connection
33
33
Device Sensing Problem
28
28
Battery Problem
25
25
Signal Artifact/Noise
23
23
Electrical /Electronic Property Problem
20
20
Unintended Application Program Shut Down
18
18
Output Problem
15
15
Failure to Sense
12
12
Application Program Problem
10
10
Communication or Transmission Problem
10
10
No Device Output
10
10
Sensing Intermittently
10
10
Display or Visual Feedback Problem
9
9
Loose or Intermittent Connection
7
7
Temperature Problem
7
7
Noise, Audible
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Device Misassembled During Manufacturing /Shipping
6
6
Energy Output Problem
5
5
Intermittent Continuity
5
5
Unexpected Shutdown
5
5
Fitting Problem
5
5
Failure to Deliver Energy
5
5
Therapeutic or Diagnostic Output Failure
3
3
Intermittent Loss of Power
3
3
Failure to Deliver Shock/Stimulation
2
2
Overheating of Device
2
2
Failure of Device to Self-Test
2
2
No Apparent Adverse Event
2
2
Defibrillation/Stimulation Problem
2
2
Material Deformation
2
2
Device Fell
2
2
Wireless Communication Problem
2
2
Device Alarm System
2
2
Low Readings
1
1
Audible Prompt/Feedback Problem
1
1
Electrical Shorting
1
1
Material Twisted/Bent
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1565
1565
No Consequences Or Impact To Patient
48
48
Insufficient Information
36
36
Nerve Damage
21
21
Superficial (First Degree) Burn
13
13
No Known Impact Or Consequence To Patient
5
5
Burn(s)
5
5
Paralysis
4
4
Paresis
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Numbness
3
3
Unintended Extubation
3
3
Convulsion/Seizure
2
2
Loss of consciousness
2
2
Hemorrhage/Bleeding
2
2
Dysphasia
1
1
Electric Shock
1
1
Speech Disorder
1
1
Brain Injury
1
1
Fatigue
1
1
Diaphoresis
1
1
Dizziness
1
1
Muscle Weakness
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Confusion/ Disorientation
1
1
Unspecified Nervous System Problem
1
1
No Patient Involvement
1
1
Twitching
1
1
Muscular Rigidity
1
1
Laceration(s)
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Tachycardia
1
1
Stenosis
1
1
Ambulation Difficulties
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cadwell Industries Inc
II
Jul-12-2024
2
Cadwell Industries Inc
II
May-22-2024
3
Medtronic Xomed, Inc.
II
Apr-18-2025
4
Medtronic Xomed, Inc.
I
Jul-24-2024
5
Medtronic Xomed, Inc.
II
Jun-02-2022
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