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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 2017
8 8 10 29 34 33 33 27 40 30 18

Device Problems
No Known Device Problem 5279
Device operates differently than expected 3311
Volume accuracy issue 2650
Pumping stopped 2280
Replace 1822
No Information 1774
Device displays error message 1617
Device remains implanted 1460
Explanted 1400
Improper or incorrect procedure or method 1220
Aspiration issue 1219
Unknown (for use when the device problem is not known) 1131
Insufficient flow or underinfusion 1056
Occlusion within device 891
Material integrity issue 888
Migration of device or device component 826
Failure to service 753
Kinked 739
Intermittent infusion 714
Unstable 691
Filling problem 648
Electro-magnetic interference (EMI) 599
Motor drive unit (MDU) stalled or jammed 594
Disconnection 509
Inappropriate or unexpected reset 504
Implant, reprogramming of 448
Repair 395
Tears, rips, holes in device, device material 389
Fluid leak 375
Fracture 371
Excess flow or overinfusion 354
Dislodged 344
Leak 308
Not audible alarm 271
Device alarm system issue 229
Alarm, audible 227
Nonstandard device or device component 224
Break 219
Tipover 218
Implant, repositioning of 211
Dislodged or dislocated 201
Low battery 199
Device or device fragments location unknown 193
Human-Device Interface Issue 190
Other (for use when an appropriate device code cannot be identified) 181
Malposition of device 169
Battery issue 163
Difficult to position 160
Fibrosis 155
Malfunction 152
Premature elective replacement indicator 149
Device, or device fragments remain in patient 113
Blockage within device or device component 108
Coiled 108
Aspiration, incomplete 105
Positioning Issue 96
Reset issue 95
Device Issue 91
Infusion or flow issue 88
Internal fixation, revision of 76
Premature explantation 76
Failure to interrogate 75
Component(s), broken 75
Loose or intermittent connection 74
Unintended movement 72
Communication or transmission issue 71
Magnetic interference 69
Hole in material 66
Device stops intermittently 66
Protective measure issue 66
Device ingredient or reagent issue 65
Mechanical jam 64
Cut in material 62
Electro-magnetic interference (EMI), compatibility/incompatibility 61
Reaction 61
Pumping issue 60
Data Issue 60
No code available 57
Incorrect software programming calculations 55
Failure to disconnect 53
Implant, removal of 49
Difficult to interrogate 48
Premature discharge of battery 46
Application program issue 44
Electromagnetic compatibility issue 44
Detachment of device component 43
Use of Device Issue 42
Failure to expand 41
Torn material 40
Suspect EMI 40
Programming issue 36
Difficult to advance 33
Low audible alarm 33
Temperature issue 31
Slippage of device or device component 30
Material erosion 29
Size incorrect for patient 28
Accuracy rate 27
Deployment issue 27
Connection issue 27
Total Device Problems 43996

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 3 1 0 2 1 5 0 0 1 0
Class II 0 5 2 2 0 1 0 5 2 1 1
Class III 0 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-29-2017
6 Medtronic Neuromodulation I Dec-19-2016
7 Medtronic Neuromodulation II Mar-29-2016
8 Medtronic Neuromodulation II May-28-2015
9 Medtronic Neuromodulation II Aug-08-2014
10 Medtronic Neuromodulation II Jun-04-2014
11 Medtronic Neuromodulation II May-08-2014
12 Medtronic Neuromodulation II May-08-2014
13 Medtronic Neuromodulation I Jun-25-2013
14 Medtronic Neuromodulation I Jun-25-2013
15 Medtronic Neuromodulation I Jun-24-2013
16 Medtronic Neuromodulation I Dec-13-2012
17 Medtronic Neuromodulation II Mar-30-2012
18 Medtronic Neuromodulation II Mar-29-2010
19 Medtronic Neuromodulation II Sep-29-2009
20 Medtronic Neuromodulation I Sep-10-2009
21 Medtronic Neuromodulation II Jan-26-2009
22 Medtronic Neuromodulation I Sep-25-2008
23 Medtronic Neuromodulation II Sep-17-2008
24 Medtronic Neuromodulation II Sep-03-2008
25 Medtronic Neuromodulation II Aug-27-2008
26 Medtronic Neuromodulation II Jul-22-2008
27 Medtronic Neuromodulation I Mar-22-2008
28 Medtronic Neuromodulation II Feb-09-2008
29 Medtronic Neuromodulation I Feb-02-2008
30 Medtronic, Inc. - Neuromodulation I Aug-29-2011
31 Medtronic, Inc. - Neuromodulation I Feb-10-2011
32 Medtronic, Inc. - Neuromodulation II Nov-09-2010

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