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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 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 22
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 623
Break 507
Occlusion within device 498
Explanted 302
Program, failure to 254
Performance 253
No Known Device Problem 245
Blockage within device or device component 241
Device operates differently than expected 233
Programming issue 197
No code available 184
No Information 175
No flow 142
Device Issue 118
Fracture 101
Inaccurate flowrate 98
Disconnection 97
Restricted flowrate 77
Use of Device Issue 75
Excess flow or overinfusion 71
Mechanical issue 62
Dislodged or dislocated 58
Improper flow or infusion 57
Pressure issue 54
Tears, rips, holes in device, device material 54
Insufficient flow or underinfusion 53
Obstruction within device 47
Migration of device or device component 41
Valve(s), failure of 36
Mechanical jam 32
Malfunction 31
Difficult to Program or Calibrate 29
Crack 20
Cut in material 19
Hole in material 17
Device damaged prior to use 16
Device, or device fragments remain in patient 14
Reflux within device 13
Decrease in pressure 13
Infusion or flow issue 12
Connection issue 11
Detachment of device or device component 10
Shunts, failure of 9
Kinked 9
Fluid leak 8
Material separation 8
Torn material 8
Unknown (for use when the device problem is not known) 7
Overheating of device or device component 7
Failure to prime 7
Product quality issue 7
Device remains implanted 6
Air leak 6
Detachment of device component 6
Foreign material present in device 6
Device inoperable 5
Device disinfection or sterilization issue 5
Defective item 5
Device or device fragments location unknown 5
Bent 5
Loose or intermittent connection 5
Valve(s), sticking 5
Sticking 5
Difficult to remove 4
Failure to flush 4
Filling problem 4
Device displays error message 4
Split 4
Packaging issue 4
Item contaminated during manufacturing or shipping 3
Improper device output 3
Physical resistance 3
Improper or incorrect procedure or method 3
Material rupture 3
Failure to pump 3
Material puncture 3
Output above specifications 2
Sterility 2
Retraction problem 2
Material fragmentation 2
Material frayed 2
Loss of or failure to bond 2
Component missing 2
Malposition of device 2
Blocked connection 2
Device markings issue 2
Device or device component damaged by another device 2
Difficult to advance 2
Incorrect device or component shipped 2
Free or unrestricted flow 2
Failure to auto stop 2
Material integrity issue 2
Positioning Issue 2
Unintended movement 2
Device handling issue 2
Noise, Audible 2
Output below specifications 1
Filtration issue 1
Device packaging compromised 1
Total Device Problems 6467

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 1 1 0 0 0 0 1 0 0 1
Class II 0 0 1 0 0 2 3 8 1 1 1
Class III 0 0 0 0 0 0 0 1 0 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 Apr-07-2017
19 Medtronic Neurosurgery II Feb-02-2017
20 Medtronic Neurosurgery I Jun-27-2014
21 Medtronic Neurosurgery II Nov-26-2013
22 Medtronic Neurosurgery I Mar-27-2009

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