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TPLC
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Device
stimulator, electrical, evoked response
Product Code
GWF
Regulation Number
882.1870
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALPHATEC SPINE, INC.
SUBSTANTIALLY EQUIVALENT
1
CADWELL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
INOMED MEDIZINTECHNIK GMBH
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC XOMED, INC.
SUBSTANTIALLY EQUIVALENT
1
NEUROSOFT LTD
SUBSTANTIALLY EQUIVALENT
1
SAFEOP SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SOTERIX MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
94
94
2020
65
65
2021
54
54
2022
45
45
2023
150
150
2024
68
68
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
218
218
Incorrect, Inadequate or Imprecise Result or Readings
75
75
Failure to Power Up
25
25
Device Sensing Problem
22
22
Inappropriate Audible Prompt/Feedback
21
21
Break
21
21
Connection Problem
20
20
False Positive Result
14
14
Unable to Obtain Readings
14
14
Output Problem
13
13
False Negative Result
12
12
Failure to Deliver Energy
10
10
Computer Software Problem
9
9
Application Program Problem
9
9
Mechanical Problem
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Unintended Application Program Shut Down
8
8
Failure to Sense
7
7
Insufficient Information
6
6
Communication or Transmission Problem
5
5
Energy Output Problem
5
5
Signal Artifact/Noise
5
5
Display or Visual Feedback Problem
5
5
Electrical /Electronic Property Problem
5
5
Intermittent Continuity
4
4
Detachment of Device or Device Component
4
4
Application Program Freezes, Becomes Nonfunctional
4
4
Device Misassembled During Manufacturing /Shipping
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Apparent Adverse Event
3
3
Noise, Audible
3
3
Loose or Intermittent Connection
3
3
Sensing Intermittently
3
3
Defective Component
2
2
Power Problem
2
2
Temperature Problem
2
2
Fitting Problem
2
2
Failure of Device to Self-Test
1
1
Impedance Problem
1
1
Inadequate User Interface
1
1
Material Deformation
1
1
Wireless Communication Problem
1
1
Complete Loss of Power
1
1
Unexpected Shutdown
1
1
Data Problem
1
1
Incomplete or Inadequate Connection
1
1
Key or Button Unresponsive/not Working
1
1
Low Readings
1
1
Battery Problem
1
1
Intermittent Shock/Stimulation
1
1
Improper or Incorrect Procedure or Method
1
1
Failure to Read Input Signal
1
1
Smoking
1
1
Overheating of Device
1
1
Loss of Power
1
1
Device Emits Odor
1
1
Entrapment of Device
1
1
Material Fragmentation
1
1
Image Display Error/Artifact
1
1
Failure to Deliver Shock/Stimulation
1
1
Crack
1
1
No Display/Image
1
1
Device Alarm System
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
326
326
No Consequences Or Impact To Patient
120
120
No Known Impact Or Consequence To Patient
21
21
No Information
5
5
No Patient Involvement
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Nerve Damage
3
3
Paralysis
2
2
Tachycardia
2
2
Numbness
2
2
Loss of consciousness
2
2
Insufficient Information
2
2
Convulsion/Seizure
2
2
Cramp(s) /Muscle Spasm(s)
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Unintended Extubation
1
1
Device Embedded In Tissue or Plaque
1
1
Not Applicable
1
1
Brain Injury
1
1
Stenosis
1
1
No Code Available
1
1
Diaphoresis
1
1
Low Oxygen Saturation
1
1
Ambulation Difficulties
1
1
Confusion/ Disorientation
1
1
Bronchospasm
1
1
Tissue Damage
1
1
Twitching
1
1
Dizziness
1
1
Dysphasia
1
1
Paresis
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Burn(s)
1
1
Death
1
1
Fatigue
1
1
Hemorrhage/Bleeding
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Xomed, Inc.
II
Jun-02-2022
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