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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shunt, central nervous system and components
Regulation Description Central nervous system fluid shunt and components.
Product CodeJXG
Regulation Number 882.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 8
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 20
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 18
INTEGRA
  SUBSTANTIALLY EQUIVALENT 27
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 19
NEUROCARE GROUP
  SUBSTANTIALLY EQUIVALENT 1
NMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
PHOENIX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 11
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 3
SOPHYSA SA
  SUBSTANTIALLY EQUIVALENT 7
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 1055
Leak 531
Break 390
Occlusion within device 329
Explanted 302
Program, failure to 254
Performance 253
Blockage within device or device component 213
No Known Device Problem 153
Device Issue 117
No flow 108
No code available 103
No Information 95
Fracture 92
Device operates differently than expected 87
Programming issue 86
Disconnection 81
Restricted flowrate 77
Use of Device Issue 65
Mechanical issue 59
Inaccurate flowrate 58
Tears, rips, holes in device, device material 54
Excess flow or overinfusion 41
Pressure issue 40
Improper flow or infusion 39
Valve(s), failure of 36
Dislodged or dislocated 32
Malfunction 31
Insufficient flow or underinfusion 30
Migration of device or device component 21
Obstruction within device 20
Cut in material 19
Difficult to Program or Calibrate 18
Hole in material 15
Crack 14
Device, or device fragments remain in patient 14
Device damaged prior to use 14
Reflux within device 12
Decrease in pressure 11
Mechanical jam 11
Shunts, failure of 9
Infusion or flow issue 7
Detachment of device or device component 7
Unknown (for use when the device problem is not known) 7
Device remains implanted 6
Material separation 6
Air leak 6
Kinked 5
Device inoperable 5
Valve(s), sticking 5
Sticking 5
Device disinfection or sterilization issue 5
Foreign material present in device 5
Defective item 4
Packaging issue 4
Torn material 4
Failure to prime 4
Difficult to remove 4
Loose or intermittent connection 4
Detachment of device component 4
Bent 4
Fluid leak 4
Failure to pump 3
Split 3
Item contaminated during manufacturing or shipping 3
Improper device output 3
Free or unrestricted flow 2
Incorrect device or component shipped 2
Connection issue 2
Device or device component damaged by another device 2
Physical resistance 2
Device handling issue 2
Noise, Audible 2
Positioning Issue 2
Material puncture 2
Product quality issue 2
Retraction problem 2
Sterility 2
Loss of or failure to bond 2
Output above specifications 2
Filling problem 2
Material fragmentation 2
Gel leak 1
False reading from device non-compliance 1
Difficult to insert 1
Laser pulse timing error 1
Device alarm system issue 1
Use of Incorrect Control Settings 1
Component(s), broken 1
Failure to flush 1
Display misread 1
Device stops intermittently 1
Tip breakage 1
Failure to zero 1
Fitting problem 1
Material rupture 1
Self-activation or keying 1
Increase in pressure 1
Difficult to position 1
Premature explantation 1
Total Device Problems 5156

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 1 1 0 0 0 0 1 0 0
Class II 0 0 1 0 0 2 3 8 1 0
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra Neuro Sciences II Sep-08-2009
2 Aesculap, Inc. II Jan-26-2015
3 Aesculap, Inc. III Dec-16-2014
4 Aesculap, Inc. II Dec-03-2014
5 Aesculap, Inc. II Jun-02-2014
6 Aesculap, Inc. II Feb-19-2014
7 Aesculap, Inc. II Feb-12-2013
8 Codman & Shurtleff, Inc. II Oct-20-2014
9 Codman & Shurtleff, Inc. II Aug-12-2014
10 Codman & Shurtleff, Inc. II Apr-17-2014
11 Codman & Shurtleff, Inc. II Jan-29-2014
12 Integra LifeSciences Corp II Jul-10-2012
13 Integra LifeSciences Corp. II Jan-03-2014
14 Integra LifeSciences Corp. I Dec-12-2008
15 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-20-2013
16 Integra Neurosciences PR, Inc. II Feb-16-2012
17 Medtronic Neurosurgery I Jun-27-2014
18 Medtronic Neurosurgery II Nov-26-2013
19 Medtronic Neurosurgery I Mar-27-2009

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