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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 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 582
Break 447
Occlusion within device 423
Explanted 302
Program, failure to 254
Performance 253
Blockage within device or device component 221
No Known Device Problem 196
Programming issue 130
No code available 130
No flow 129
No Information 122
Device Issue 118
Device operates differently than expected 105
Fracture 100
Disconnection 91
Restricted flowrate 77
Use of Device Issue 74
Inaccurate flowrate 72
Excess flow or overinfusion 61
Mechanical issue 61
Tears, rips, holes in device, device material 54
Improper flow or infusion 50
Pressure issue 49
Insufficient flow or underinfusion 44
Dislodged or dislocated 43
Valve(s), failure of 36
Malfunction 31
Migration of device or device component 30
Obstruction within device 28
Difficult to Program or Calibrate 25
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
Fluid leak 7
Kinked 7
Air leak 6
Device remains implanted 6
Foreign material present in device 6
Torn material 6
Device disinfection or sterilization issue 5
Defective item 5
Sticking 5
Device inoperable 5
Valve(s), sticking 5
Detachment of device component 5
Bent 4
Loose or intermittent connection 4
Filling problem 4
Failure to flush 4
Difficult to remove 4
Split 4
Connection issue 4
Packaging issue 4
Item contaminated during manufacturing or shipping 3
Improper device output 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
Difficult to advance 2
Incorrect device or component shipped 2
Free or unrestricted flow 2
Device or device component damaged by another device 2
Device displays error message 2
Physical resistance 2
Positioning Issue 2
Unintended movement 2
Device handling issue 2
Noise, Audible 2
Material integrity issue 1
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
Malposition of device 1
Patient-device incompatibility 1
Aspiration issue 1
Total Device Problems 5726

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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