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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 7
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 62
Device operates differently than expected 47
Device displays error message 41
Pressure sensor failure 32
Use of Device Issue 26
Artifact 22
Low readings 20
No Known Device Problem 19
Device handling issue 15
Leak 13
Failure to power-up 11
High Readings 11
No display or display failure 11
Incorrect or inadequate result 10
Unable to obtain readings 10
Incorrect display 9
Device inoperable 9
False reading from device non-compliance 8
Device sensing issue 7
Crack 7
Failure to zero 6
Pressure issue 6
Improper device output 6
Migration of device or device component 6
Increase in pressure 6
Connection issue 6
Failure to sense 5
Device Issue 5
No device output 5
Defective item 5
Disconnection 5
Grounding malfunction 4
Loose or intermittent connection 4
Incorrect or inadequate test results 4
Temperature issue 4
Loss of power 4
Out-of-box failure 4
Image display error 4
Battery issue 4
Defective component 4
No code available 4
Incorrect measurement 4
Device stops intermittently 3
Improper or incorrect procedure or method 3
Communication or transmission issue 3
Fracture 3
Material separation 3
No Information 3
Fluid leak 2
Mechanical issue 2
Device alarm system issue 2
Device damaged prior to use 2
Low battery 2
Computer operating system issue 2
Detachment of device component 2
Low test results 2
Unintended movement 2
Bent 2
Difficult to remove 2
Charging issue 2
Issue with displayed error message 2
Material integrity issue 2
Material puncture 2
High test results 2
Inappropriate or unexpected reset 1
Premature discharge of battery 1
Continuous firing 1
Device remains activated 1
No flow 1
Explanted 1
Not audible alarm 1
Loss of or failure to bond 1
Failure to charge 1
Disassembly 1
Power source issue 1
Data Issue 1
Increased sensitivity 1
Application interface becomes non-functional or program exits abnormally 1
Display misread 1
Image resolution poor 1
Electronic property issue 1
Device, or device fragments remain in patient 1
Tube(s), buckling of 1
Foreign material present in device 1
Improper alarm 1
Material deformation 1
Device packaging compromised 1
Mechanical jam 1
Electro-magnetic interference (EMI) 1
Material fragmentation 1
Wire(s), breakage of 1
Defective Alarm 1
Burn of device or device component 1
Component falling 1
Erratic display 1
Restricted flowrate 1
Component(s), broken 1
Nonstandard device or device component 1
Detachment of device or device component 1
Total Device Problems 756

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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