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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 26

Device Problems
No Known Device Problem 4103
Volume accuracy issue 2266
Device operates differently than expected 2160
Pumping stopped 1842
Replace 1822
No Information 1772
Device remains implanted 1460
Explanted 1400
Unknown (for use when the device problem is not known) 1131
Device displays error message 1036
Improper or incorrect procedure or method 1023
Aspiration issue 900
Insufficient flow or underinfusion 842
Occlusion within device 766
Migration of device or device component 686
Kinked 636
Motor drive unit (MDU) stalled or jammed 594
Material integrity issue 541
Filling problem 508
Electro-magnetic interference (EMI) 488
Failure to service 456
Disconnection 450
Intermittent infusion 449
Implant, reprogramming of 448
Unstable 447
Repair 395
Tears, rips, holes in device, device material 389
Fracture 371
Dislodged 344
Leak 306
Inappropriate or unexpected reset 294
Fluid leak 264
Excess flow or overinfusion 249
Alarm, audible 227
Nonstandard device or device component 224
Break 219
Tipover 218
Implant, repositioning of 211
Dislodged or dislocated 201
Low battery 198
Not audible alarm 197
Device alarm system issue 185
Other (for use when an appropriate device code cannot be identified) 181
Difficult to position 160
Fibrosis 155
Malfunction 152
Human-Device Interface Issue 148
Malposition of device 146
Device or device fragments location unknown 131
Battery issue 124
Device, or device fragments remain in patient 113
Blockage within device or device component 108
Coiled 108
Aspiration, incomplete 105
Reset issue 95
Infusion or flow issue 88
Device Issue 85
Internal fixation, revision of 76
Premature explantation 76
Component(s), broken 75
Loose or intermittent connection 74
Premature elective replacement indicator 73
Unintended movement 72
Positioning Issue 70
Magnetic interference 69
Hole in material 66
Device stops intermittently 66
Reaction 61
Electro-magnetic interference (EMI), compatibility/incompatibility 61
Cut in material 61
Pumping issue 60
Communication or transmission issue 56
Incorrect software programming calculations 55
Failure to interrogate 53
Implant, removal of 49
Device ingredient or reagent issue 48
Premature discharge of battery 46
No code available 46
Electromagnetic compatibility issue 44
Detachment of device component 42
Use of Device Issue 42
Mechanical jam 41
Suspect EMI 40
Failure to disconnect 40
Programming issue 36
Protective measure issue 36
Data Issue 35
Difficult to interrogate 34
Low audible alarm 33
Application program issue 33
Torn material 33
Slippage of device or device component 30
Material erosion 29
Failure to expand 29
Accuracy rate 27
Inappropriate shock 26
No flow 25
Material twisted 24
Program, failure to 24
Failure to infuse 24
Total Device Problems 36657

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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