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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 64
Device operates differently than expected 49
Device displays error message 43
Pressure sensor failure 32
Use of Device Issue 30
Low readings 22
Artifact 22
No Known Device Problem 19
Device handling issue 15
High Readings 14
Leak 13
Unable to obtain readings 12
Failure to power-up 11
No display or display failure 11
Device inoperable 10
Incorrect or inadequate result 10
Incorrect display 9
False reading from device non-compliance 8
Crack 8
Disconnection 8
Device sensing issue 8
Failure to zero 7
Increase in pressure 6
Migration of device or device component 6
Improper device output 6
Connection issue 6
Pressure issue 6
Defective item 5
Battery issue 5
No device output 5
Failure to sense 5
Device Issue 5
Incorrect or inadequate test results 4
Defective component 4
Out-of-box failure 4
Loss of power 4
Grounding malfunction 4
Image display error 4
Loose or intermittent connection 4
Incorrect measurement 4
Temperature issue 4
No code available 4
No Information 3
Communication or transmission issue 3
Fracture 3
Material separation 3
Device stops intermittently 3
Improper or incorrect procedure or method 3
Device damaged prior to use 2
High test results 2
Low test results 2
Low battery 2
Difficult to remove 2
Fluid leak 2
Material puncture 2
Mechanical issue 2
Bent 2
Detachment of device component 2
Device alarm system issue 2
Computer operating system issue 2
Charging issue 2
Issue with displayed error message 2
Unintended movement 2
Data Issue 2
Power source issue 2
Material integrity issue 2
Mechanical jam 1
No flow 1
Packaging issue 1
Torn material 1
Noise, Audible 1
Material deformation 1
Inappropriate or unexpected reset 1
Electronic property issue 1
Foreign material present in device 1
Improper alarm 1
Detachment of device or device component 1
Device packaging compromised 1
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
Display misread 1
Erratic display 1
Application interface becomes non-functional or program exits abnormally 1
Disassembly 1
Image resolution poor 1
Nonstandard device or device component 1
Material fragmentation 1
Restricted flowrate 1
Electro-magnetic interference (EMI) 1
Explanted 1
Device remains activated 1
Device, or device fragments remain in patient 1
Total Device Problems 783

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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