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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 9

Device Problems
No Known Device Problem 3196
Volume accuracy issue 1973
Replace 1822
No Information 1770
Device operates differently than expected 1541
Pumping stopped 1523
Device remains implanted 1460
Explanted 1400
Unknown (for use when the device problem is not known) 1131
Improper or incorrect procedure or method 900
Aspiration issue 682
Occlusion within device 666
Insufficient flow or underinfusion 655
Device displays error message 603
Motor drive unit (MDU) stalled or jammed 594
Migration of device or device component 594
Kinked 539
Implant, reprogramming of 448
Disconnection 414
Filling problem 412
Electro-magnetic interference (EMI) 405
Repair 395
Tears, rips, holes in device, device material 389
Fracture 371
Dislodged 344
Material integrity issue 307
Leak 304
Intermittent infusion 274
Unstable 228
Alarm, audible 227
Nonstandard device or device component 224
Tipover 218
Break 217
Failure to service 212
Implant, repositioning of 211
Dislodged or dislocated 200
Low battery 196
Other (for use when an appropriate device code cannot be identified) 181
Excess flow or overinfusion 180
Fluid leak 169
Fibrosis 155
Difficult to position 153
Malfunction 152
Not audible alarm 151
Inappropriate or unexpected reset 139
Device alarm system issue 136
Malposition of device 134
Human-Device Interface Issue 115
Device, or device fragments remain in patient 113
Blockage within device or device component 108
Coiled 108
Aspiration, incomplete 105
Battery issue 102
Reset issue 94
Infusion or flow issue 88
Device or device fragments location unknown 83
Device Issue 81
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
Reaction 61
Electro-magnetic interference (EMI), compatibility/incompatibility 61
Cut in material 61
Pumping issue 59
Positioning Issue 57
Incorrect software programming calculations 55
Implant, removal of 49
Premature elective replacement indicator 46
Premature discharge of battery 46
Failure to interrogate 44
Electromagnetic compatibility issue 44
Communication or transmission issue 42
Detachment of device component 41
Suspect EMI 40
Use of Device Issue 40
Programming issue 36
No code available 33
Low audible alarm 33
Device ingredient or reagent issue 32
Failure to disconnect 30
Slippage of device or device component 30
Material erosion 29
Torn material 29
Application program issue 28
Accuracy rate 27
Inappropriate shock 26
No flow 25
Material twisted 24
Failure to infuse 24
Program, failure to 23
Alarm, intermittent 23
Mechanical jam 23
Improper flow or infusion 23
Data Issue 22
Computer software issue 22
Total Device Problems 31452

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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