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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 21
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 543
Break 408
Occlusion within device 370
Explanted 302
Program, failure to 254
Performance 253
Blockage within device or device component 217
No Known Device Problem 171
Device Issue 118
No flow 115
No code available 111
No Information 106
Programming issue 102
Fracture 94
Device operates differently than expected 87
Disconnection 86
Restricted flowrate 77
Use of Device Issue 74
Mechanical issue 61
Inaccurate flowrate 59
Tears, rips, holes in device, device material 54
Improper flow or infusion 46
Excess flow or overinfusion 45
Pressure issue 43
Dislodged or dislocated 39
Insufficient flow or underinfusion 36
Valve(s), failure of 36
Malfunction 31
Migration of device or device component 24
Difficult to Program or Calibrate 22
Obstruction within device 21
Cut in material 19
Hole in material 16
Crack 16
Device, or device fragments remain in patient 14
Device damaged prior to use 14
Mechanical jam 14
Decrease in pressure 12
Reflux within device 12
Shunts, failure of 9
Infusion or flow issue 8
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 6
Sticking 5
Valve(s), sticking 5
Device inoperable 5
Failure to prime 5
Defective item 5
Device disinfection or sterilization issue 5
Foreign material present in device 5
Torn material 5
Packaging issue 4
Difficult to remove 4
Loose or intermittent connection 4
Filling problem 4
Detachment of device component 4
Bent 4
Fluid leak 4
Failure to pump 3
Improper device output 3
Item contaminated during manufacturing or shipping 3
Split 3
Physical resistance 2
Device displays error message 2
Incorrect device or component shipped 2
Difficult to advance 2
Free or unrestricted flow 2
Device or device component damaged by another device 2
Connection issue 2
Positioning Issue 2
Device handling issue 2
Noise, Audible 2
Material puncture 2
Product quality issue 2
Retraction problem 2
Improper or incorrect procedure or method 2
Sterility 2
Loss of or failure to bond 2
Failure to flush 2
Material fragmentation 2
Output above specifications 2
Laser pulse timing error 1
Gel leak 1
Difficult to insert 1
False reading from device non-compliance 1
Device alarm system issue 1
Use of Incorrect Control Settings 1
Component(s), broken 1
Difficult to flush 1
Display misread 1
Incorrect display 1
Device stops intermittently 1
Tip breakage 1
Failure to zero 1
Material rupture 1
Total Device Problems 5364

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 1
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 Sep-30-2016
14 Integra LifeSciences Corp. II Jan-03-2014
15 Integra LifeSciences Corp. I Dec-12-2008
16 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Dec-20-2013
17 Integra Neurosciences PR, Inc. II Feb-16-2012
18 Medtronic Neurosurgery I Jun-27-2014
19 Medtronic Neurosurgery II Nov-26-2013
20 Medtronic Neurosurgery I Mar-27-2009

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