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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 577
Break 440
Occlusion within device 413
Explanted 302
Program, failure to 254
Performance 253
Blockage within device or device component 218
No Known Device Problem 186
No flow 127
Programming issue 124
No Information 120
Device Issue 118
No code available 117
Device operates differently than expected 98
Fracture 96
Disconnection 87
Restricted flowrate 77
Use of Device Issue 74
Inaccurate flowrate 71
Mechanical issue 61
Excess flow or overinfusion 58
Tears, rips, holes in device, device material 54
Improper flow or infusion 50
Pressure issue 47
Insufficient flow or underinfusion 42
Dislodged or dislocated 41
Valve(s), failure of 36
Malfunction 31
Migration of device or device component 30
Obstruction within device 26
Difficult to Program or Calibrate 24
Cut in material 19
Crack 18
Hole in material 16
Device damaged prior to use 15
Mechanical jam 15
Device, or device fragments remain in patient 14
Decrease in pressure 13
Reflux within device 13
Shunts, failure of 9
Material separation 8
Infusion or flow issue 8
Detachment of device or device component 8
Unknown (for use when the device problem is not known) 7
Failure to prime 7
Product quality issue 7
Kinked 7
Air leak 6
Device remains implanted 6
Torn material 6
Defective item 5
Device disinfection or sterilization issue 5
Foreign material present in device 5
Sticking 5
Device inoperable 5
Valve(s), sticking 5
Detachment of device component 5
Bent 4
Fluid leak 4
Loose or intermittent connection 4
Filling problem 4
Failure to flush 4
Difficult to remove 4
Split 4
Packaging issue 4
Improper device output 3
Item contaminated during manufacturing or shipping 3
Connection issue 3
Failure to pump 3
Material puncture 2
Retraction problem 2
Improper or incorrect procedure or method 2
Sterility 2
Material fragmentation 2
Output above specifications 2
Loss of or failure to bond 2
Device displays error message 2
Device or device component damaged by another device 2
Incorrect device or component shipped 2
Difficult to advance 2
Free or unrestricted flow 2
Physical resistance 2
Positioning Issue 2
Device handling issue 2
Noise, Audible 2
Unintended movement 2
Failure to cut 1
Device or device fragments location unknown 1
Pressure, insufficient 1
Material perforation 1
Fitting problem 1
Valve(s), defective 1
Bacterial contamination of device 1
Component missing 1
Implant, reprogramming of 1
Material integrity issue 1
Device-device incompatibility 1
Device markings issue 1
Patient-device incompatibility 1
Total Device Problems 5635

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 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 II Feb-02-2017
19 Medtronic Neurosurgery I Jun-27-2014
20 Medtronic Neurosurgery II Nov-26-2013
21 Medtronic Neurosurgery I Mar-27-2009

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