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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 565
Break 428
Occlusion within device 402
Explanted 302
Program, failure to 254
Performance 253
Blockage within device or device component 218
No Known Device Problem 182
No flow 122
Device Issue 118
No Information 118
No code available 117
Programming issue 111
Fracture 96
Device operates differently than expected 94
Disconnection 87
Restricted flowrate 77
Use of Device Issue 74
Inaccurate flowrate 69
Mechanical issue 61
Tears, rips, holes in device, device material 54
Excess flow or overinfusion 52
Improper flow or infusion 48
Pressure issue 46
Dislodged or dislocated 41
Insufficient flow or underinfusion 39
Valve(s), failure of 36
Malfunction 31
Migration of device or device component 26
Difficult to Program or Calibrate 23
Obstruction within device 21
Cut in material 19
Crack 17
Hole in material 16
Mechanical jam 15
Device damaged prior to use 14
Device, or device fragments remain in patient 14
Reflux within device 12
Decrease in pressure 12
Shunts, failure of 9
Infusion or flow issue 8
Failure to prime 7
Product quality issue 7
Unknown (for use when the device problem is not known) 7
Material separation 7
Detachment of device or device component 7
Kinked 6
Device remains implanted 6
Air leak 6
Sticking 5
Foreign material present in device 5
Valve(s), sticking 5
Device disinfection or sterilization issue 5
Torn material 5
Defective item 5
Device inoperable 5
Bent 4
Difficult to remove 4
Packaging issue 4
Failure to flush 4
Filling problem 4
Fluid leak 4
Loose or intermittent connection 4
Detachment of device component 4
Item contaminated during manufacturing or shipping 3
Split 3
Improper device output 3
Failure to pump 3
Retraction problem 2
Material puncture 2
Loss of or failure to bond 2
Output above specifications 2
Device displays error message 2
Connection issue 2
Improper or incorrect procedure or method 2
Physical resistance 2
Sterility 2
Noise, Audible 2
Positioning Issue 2
Free or unrestricted flow 2
Difficult to advance 2
Unintended movement 2
Incorrect device or component shipped 2
Device or device component damaged by another device 2
Material fragmentation 2
Device handling issue 2
Use of Incorrect Control Settings 1
Device-device incompatibility 1
Failure to zero 1
Aspiration issue 1
Fitting problem 1
Material rupture 1
Difficult to insert 1
Device alarm system issue 1
Device markings issue 1
Difficult to position 1
Material perforation 1
Bacterial contamination of device 1
Gel leak 1
Total Device Problems 5537

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

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