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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, evoked response
Product CodeGWF
Regulation Number 882.1870
Device Class 2


Premarket Reviews
ManufacturerDecision
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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