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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, implanted, programmable
Product CodeLKK
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
8 8 10 29 34 33 33 27 40 24

Device Problems
No Known Device Problem 3701
Volume accuracy issue 2145
Device operates differently than expected 1929
Replace 1822
No Information 1771
Pumping stopped 1684
Device remains implanted 1460
Explanted 1400
Unknown (for use when the device problem is not known) 1131
Improper or incorrect procedure or method 970
Device displays error message 836
Aspiration issue 805
Insufficient flow or underinfusion 767
Occlusion within device 711
Migration of device or device component 630
Kinked 598
Motor drive unit (MDU) stalled or jammed 594
Filling problem 465
Electro-magnetic interference (EMI) 449
Implant, reprogramming of 448
Material integrity issue 434
Disconnection 429
Repair 395
Tears, rips, holes in device, device material 389
Fracture 371
Intermittent infusion 364
Failure to service 346
Dislodged 344
Unstable 338
Leak 305
Excess flow or overinfusion 229
Alarm, audible 227
Nonstandard device or device component 224
Fluid leak 220
Inappropriate or unexpected reset 219
Break 218
Tipover 218
Implant, repositioning of 211
Dislodged or dislocated 200
Low battery 197
Other (for use when an appropriate device code cannot be identified) 181
Not audible alarm 176
Device alarm system issue 165
Difficult to position 155
Fibrosis 155
Malfunction 152
Malposition of device 140
Human-Device Interface Issue 135
Battery issue 117
Device, or device fragments remain in patient 113
Blockage within device or device component 108
Coiled 108
Aspiration, incomplete 105
Device or device fragments location unknown 105
Reset issue 94
Infusion or flow issue 88
Device Issue 84
Internal fixation, revision of 76
Premature explantation 76
Component(s), broken 75
Loose or intermittent connection 73
Unintended movement 72
Magnetic interference 69
Device stops intermittently 66
Hole in material 65
Positioning Issue 65
Premature elective replacement indicator 61
Reaction 61
Electro-magnetic interference (EMI), compatibility/incompatibility 61
Cut in material 61
Pumping issue 60
Incorrect software programming calculations 55
Failure to interrogate 51
Communication or transmission issue 51
Implant, removal of 49
Premature discharge of battery 46
Electromagnetic compatibility issue 44
Device ingredient or reagent issue 43
Use of Device Issue 42
Detachment of device component 42
No code available 42
Suspect EMI 40
Failure to disconnect 36
Programming issue 36
Low audible alarm 33
Application program issue 32
Data Issue 32
Torn material 32
Mechanical jam 31
Slippage of device or device component 30
Material erosion 29
Accuracy rate 27
Inappropriate shock 26
Difficult to interrogate 26
No flow 25
Material twisted 24
Failure to infuse 24
Program, failure to 23
Alarm, intermittent 23
Improper flow or infusion 23
Total Device Problems 34333

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 3 1 0 2 1 5 0 0 0
Class II 0 5 2 2 0 1 0 5 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Codman & Shurtleff, Inc. II May-28-2015
2 Codman & Shurtleff, Inc. II May-09-2014
3 Codman & Shurtleff, Inc. I Sep-30-2013
4 Codman & Shurtleff, Inc. I Jul-16-2013
5 Medtronic Neuromodulation II Mar-29-2016
6 Medtronic Neuromodulation II May-28-2015
7 Medtronic Neuromodulation II Aug-08-2014
8 Medtronic Neuromodulation II Jun-04-2014
9 Medtronic Neuromodulation II May-08-2014
10 Medtronic Neuromodulation II May-08-2014
11 Medtronic Neuromodulation I Jun-25-2013
12 Medtronic Neuromodulation I Jun-25-2013
13 Medtronic Neuromodulation I Jun-24-2013
14 Medtronic Neuromodulation I Dec-13-2012
15 Medtronic Neuromodulation II Mar-30-2012
16 Medtronic Neuromodulation II Mar-29-2010
17 Medtronic Neuromodulation II Sep-29-2009
18 Medtronic Neuromodulation I Sep-10-2009
19 Medtronic Neuromodulation II Jan-26-2009
20 Medtronic Neuromodulation I Sep-25-2008
21 Medtronic Neuromodulation II Sep-17-2008
22 Medtronic Neuromodulation II Sep-03-2008
23 Medtronic Neuromodulation II Aug-27-2008
24 Medtronic Neuromodulation II Jul-22-2008
25 Medtronic Neuromodulation I Mar-22-2008
26 Medtronic Neuromodulation II Feb-09-2008
27 Medtronic Neuromodulation I Feb-02-2008
28 Medtronic, Inc. - Neuromodulation I Aug-29-2011
29 Medtronic, Inc. - Neuromodulation I Feb-10-2011
30 Medtronic, Inc. - Neuromodulation II Nov-09-2010

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