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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 36

Device Problems
No Known Device Problem 6048
Device operates differently than expected 3941
Volume accuracy issue 2895
Pumping stopped 2643
Device displays error message 1992
Replace 1822
No Information 1774
Device remains implanted 1460
Aspiration issue 1443
Explanted 1400
Improper or incorrect procedure or method 1377
Insufficient flow or underinfusion 1244
Unknown (for use when the device problem is not known) 1131
Material integrity issue 1096
Occlusion within device 993
Migration of device or device component 940
Failure to service 929
Intermittent infusion 912
Unstable 862
Kinked 806
Filling problem 736
Electro-magnetic interference (EMI) 679
Inappropriate or unexpected reset 657
Motor drive unit (MDU) stalled or jammed 594
Disconnection 545
Fluid leak 454
Implant, reprogramming of 448
Excess flow or overinfusion 435
Repair 395
Tears, rips, holes in device, device material 389
Fracture 371
Dislodged 344
Leak 311
Not audible alarm 303
Device alarm system issue 252
Device or device fragments location unknown 231
Alarm, audible 227
Human-Device Interface Issue 225
Nonstandard device or device component 224
Break 219
Tipover 218
Implant, repositioning of 211
Dislodged or dislocated 201
Low battery 199
Battery issue 190
Malposition of device 187
Other (for use when an appropriate device code cannot be identified) 181
Premature elective replacement indicator 179
Difficult to position 160
Fibrosis 155
Malfunction 152
Positioning Issue 122
Device, or device fragments remain in patient 113
Blockage within device or device component 109
Coiled 108
Aspiration, incomplete 105
Device Issue 98
Reset issue 95
Mechanical jam 92
Infusion or flow issue 88
Failure to interrogate 87
Communication or transmission issue 85
Device ingredient or reagent issue 83
Protective measure issue 79
Data Issue 76
Internal fixation, revision of 76
Premature explantation 76
Component(s), broken 75
Loose or intermittent connection 74
Unintended movement 72
Magnetic interference 69
Failure to disconnect 69
No code available 67
Device stops intermittently 66
Hole in material 66
Cut in material 63
Electro-magnetic interference (EMI), compatibility/incompatibility 61
Reaction 61
Pumping issue 60
Difficult to interrogate 58
Incorrect software programming calculations 55
Application program issue 55
Implant, removal of 49
Premature discharge of battery 46
Failure to expand 46
Detachment of device component 45
Electromagnetic compatibility issue 44
Difficult to advance 43
Use of Device Issue 43
Torn material 42
Suspect EMI 40
Size incorrect for patient 38
Connection issue 37
Programming issue 36
Temperature issue 33
Low audible alarm 33
Premature end-of-life indicator 30
Slippage of device or device component 30
Material erosion 29
Accuracy rate 27
Total Device Problems 48934

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

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