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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, monitoring, intracranial pressure
Regulation Description Intracranial pressure monitoring device.
Product CodeGWM
Regulation Number 882.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
CMA MICRODIALYSIS AB
  SUBSTANTIALLY EQUIVALENT 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 8
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 3
DIAMETRICS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INNERSPACE, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTEGRA
  SUBSTANTIALLY EQUIVALENT 13
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RAUMEDIC AG
  SUBSTANTIALLY EQUIVALENT 4
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 176
Break 75
Device operates differently than expected 51
Use of Device Issue 49
Device displays error message 47
Pressure sensor failure 32
Low readings 31
Artifact 22
No Known Device Problem 21
High Readings 17
Leak 17
Device handling issue 15
Disconnection 13
Unable to obtain readings 13
Incorrect or inadequate result 11
Failure to power-up 11
No display or display failure 11
Crack 11
Device inoperable 10
Device sensing issue 10
Incorrect display 9
False reading from device non-compliance 9
Failure to zero 8
Connection issue 7
Improper device output 6
Pressure issue 6
Increase in pressure 6
Migration of device or device component 6
No device output 5
Defective component 5
Failure to sense 5
No code available 5
Battery issue 5
Defective item 5
Device Issue 5
Incorrect or inadequate test results 4
Temperature issue 4
No Information 4
Loss of power 4
Out-of-box failure 4
Fracture 4
Loose or intermittent connection 4
Incorrect measurement 4
Grounding malfunction 4
Image display error 4
Difficult to Program or Calibrate 3
Improper or incorrect procedure or method 3
Device stops intermittently 3
Material separation 3
Communication or transmission issue 3
Computer operating system issue 2
Low battery 2
High test results 2
Low test results 2
Charging issue 2
Power source issue 2
Issue with displayed error message 2
Material integrity issue 2
Mechanical jam 2
Unintended movement 2
Data Issue 2
Difficult to remove 2
Device damaged prior to use 2
Material puncture 2
Material fragmentation 2
Fluid leak 2
Occlusion within device 2
Mechanical issue 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Defective Alarm 1
Not audible alarm 1
Premature discharge of battery 1
Burn of device or device component 1
Failure to charge 1
Component(s), broken 1
Component falling 1
Continuous firing 1
Loss of or failure to bond 1
Application interface becomes non-functional or program exits abnormally 1
Disassembly 1
Material discolored 1
Image resolution poor 1
Imprecision 1
Restricted flowrate 1
Display misread 1
Erratic display 1
Electro-magnetic interference (EMI) 1
Explanted 1
Overheating of device or device component 1
Difficult to position 1
Nonstandard device or device component 1
Failure to recalibrate 1
Device remains activated 1
Device, or device fragments remain in patient 1
Tube(s), buckling of 1
Wire(s), breakage of 1
Slippage of device or device component 1
Noise, Audible 1
Total Device Problems 861

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 2 2 2 3 3 2 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra Neuro Sciences II Aug-05-2008
2 Codman & Shurtleff, Inc. II Mar-22-2012
3 Codman & Shurtleff, Inc. II Jan-11-2012
4 Codman & Shurtleff, Inc. II Apr-20-2011
5 Integra LifeSciences Corp III Feb-03-2012
6 Integra LifeSciences Corp. II Jun-18-2015
7 Integra LifeSciences Corp. II May-15-2015
8 Integra LifeSciences Corp. II Dec-18-2014
9 Integra LifeSciences Corp. II Nov-10-2014
10 Integra LifeSciences Corp. II May-30-2014
11 Integra LifeSciences Corp. II Dec-27-2013
12 Integra LifeSciences Corp. II Oct-23-2013
13 Integra LifeSciences Corp. II Mar-03-2011
14 Integra LifeSciences Corp. II Oct-28-2010
15 Integra LifeSciences Corp. II Apr-20-2010
16 Integra Limited II Oct-30-2013

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