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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, nerve
Regulation Description Surgical nerve stimulator/locator.
Product CodeETN
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
NDI MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 6
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 2
THE MAGSTIM COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 9
WR MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device operates differently than expected 134
Incorrect or inadequate result 11
Blockage within device or device component 7
Improper or incorrect procedure or method 6
No Information 6
No Known Device Problem 5
Unknown (for use when the device problem is not known) 5
No display or display failure 4
Unable to obtain readings 4
Not audible alarm 4
Collapse 4
Failure to conduct 4
Inflation issue 4
False negative result 3
Break 3
Other (for use when an appropriate device code cannot be identified) 3
Uncoiled 3
Failure to sense 3
Defective item 3
Material puncture 3
Material Protrusion 2
Not Applicable 2
Cut in material 2
Device, or device fragments remain in patient 2
Loose or intermittent connection 2
Device alarm system issue 2
Intermittent continuity 1
Use of Incorrect Control Settings 1
Flaked 1
Restricted flowrate 1
Grounding malfunction 1
Instruction for use issue 1
Insulation degradation 1
Insulation, detached 1
Leak 1
Misassembled 1
Occlusion within device 1
Peeled 1
Increase in pressure 1
Difficult to remove 1
Electro-magnetic interference (EMI) 1
Electrical issue 1
Material separation 1
Failure to read input signal 1
Tidal volume fluctuations 1
Tip breakage 1
Tracking 1
Use of Device Issue 1
High Readings 1
Failure to advance 1
Dissatisfaction 1
Device or device fragments location unknown 1
Battery issue 1
Deployment issue 1
Reset issue 1
Torn material 1
Ventilation issue in device environment 1
Device or device component damaged by another device 1
Extrusion 1
Human-Device Interface Issue 1
Total Device Problems 265

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Mar-03-2009
2 Neurovision Medical Products Inc II Feb-22-2010

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