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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
INOMED MEDIZINTECHNIK GMBH
SUBSTANTIALLY EQUIVALENT
1
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
2018
58
58
2019
94
94
2020
65
65
2021
54
54
2022
46
46
2023
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Use of Device Problem
193
193
Mechanical Problem
18
18
Device Sensing Problem
18
18
Connection Problem
17
17
Break
16
16
Unable to Obtain Readings
11
11
Failure to Sense
11
11
Application Program Problem
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Output Problem
8
8
Unintended Application Program Shut Down
8
8
Appropriate Term/Code Not Available
7
7
Insufficient Information
6
6
Failure to Deliver Energy
6
6
Display or Visual Feedback Problem
5
5
Electrical /Electronic Property Problem
5
5
Device Operates Differently Than Expected
5
5
Sensing Intermittently
5
5
Communication or Transmission Problem
4
4
Detachment of Device or Device Component
4
4
Unexpected Shutdown
4
4
Intermittent Continuity
4
4
False Positive Result
4
4
Computer Software Problem
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Energy Output Problem
3
3
Device Stops Intermittently
3
3
Noise, Audible
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Apparent Adverse Event
3
3
Impedance Problem
3
3
Temperature Problem
2
2
Failure to Calibrate
2
2
Audible Prompt/Feedback Problem
2
2
Incomplete or Inadequate Connection
2
2
Fitting Problem
2
2
Defective Component
2
2
Overheating of Device
2
2
False Negative Result
2
2
Circuit Failure
2
2
Device Alarm System
1
1
Signal Artifact/Noise
1
1
No Display/Image
1
1
Entrapment of Device
1
1
Material Fragmentation
1
1
Image Display Error/Artifact
1
1
Loose or Intermittent Connection
1
1
Loss of Power
1
1
Device Emits Odor
1
1
Failure to Analyze Signal
1
1
Failure to Read Input Signal
1
1
Smoking
1
1
Solder Joint Fracture
1
1
Device Issue
1
1
Intermittent Shock/Stimulation
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Intermittent Program or Algorithm Execution
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Wireless Communication Problem
1
1
Complete Loss of Power
1
1
Data Problem
1
1
Low Readings
1
1
Battery Problem
1
1
Calibration Problem
1
1
Power Problem
1
1
Inadequate User Interface
1
1
Material Deformation
1
1
Failure of Device to Self-Test
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
154
154
No Clinical Signs, Symptoms or Conditions
130
130
No Known Impact Or Consequence To Patient
41
41
No Patient Involvement
9
9
No Information
5
5
Not Applicable
3
3
Nerve Damage
3
3
Insufficient Information
2
2
No Code Available
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Unintended Extubation
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Paralysis
1
1
Tachycardia
1
1
Tissue Damage
1
1
Twitching
1
1
Burn(s)
1
1
Death
1
1
Emotional Changes
1
1
Hearing Loss
1
1
Hemorrhage/Bleeding
1
1
Muscle Weakness
1
1
Lead(s), Burn(s) From
1
1
Radiation Exposure, Unintended
1
1
Device Embedded In Tissue or Plaque
1
1
Brain Injury
1
1
Depression
1
1
Paraplegia
1
1
Low Oxygen Saturation
1
1
Ambulation Difficulties
1
1
Bronchospasm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Xomed, Inc.
II
Jun-02-2022
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