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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, spinal-cord, totally implanted for pain relief
Product CodeLGW
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
20 53 38 56 47 68 71 68 72 92 14

Device Problems
Device operates differently than expected 13842
No Known Device Problem 10525
Temperature issue 5040
Migration of device or device component 4786
Charging issue 4733
Communication or transmission issue 4268
High impedance 4257
Inappropriate shock 2879
Not Applicable 2768
Impedance issue 2445
Failure to deliver energy 2337
Device displays error message 1993
Failure to charge 1840
Positioning Issue 1590
Low battery 1576
Therapy delivered to incorrect body area 1570
Battery issue 1538
No device output 1511
Use of Device Issue 1430
No Information 1224
Fracture 1211
Intermittent continuity 1075
Failure to interrogate 1057
Malposition of device 917
Unintended collision 869
Break 866
Device inoperable 806
Premature discharge of battery 795
Improper or incorrect procedure or method 791
Replace 789
Explanted 762
Low impedance 711
Unintended movement 600
Device remains implanted 586
Connection issue 574
Electro-magnetic interference (EMI) 552
Delayed charge time 525
Implant, reprogramming of 470
Unknown (for use when the device problem is not known) 441
Overheating of device or device component 436
Electromagnetic compatibility issue 428
Device stops intermittently 427
Disconnection 395
Device remains activated 384
Material integrity issue 353
Unstable 330
Output issue 307
Telemetry discrepancy 292
Kinked 276
Electronic property issue 262
Pocket stimulation 259
Unexpected therapeutic results 225
Energy output to patient tissue incorrect 219
Dislodged 187
Difficult to advance 181
Premature end-of-life indicator 179
Implant, repositioning of 177
Bent 177
Dislodged or dislocated 177
Unit inactivated 170
Device or device fragments location unknown 152
Improper device output 149
Malfunction 147
Circuit breaker tripped 137
Loss of power 130
Detachment of device component 111
Detachment of device or device component 111
Other (for use when an appropriate device code cannot be identified) 109
Lead(s), breakage of 108
Difficult to Program or Calibrate 107
Electro-magnetic interference (EMI), compatibility/incompatibility 94
Difficult to position 92
Incorrect display 88
No telemetry 88
Repair 83
Wire(s), breakage of 80
Difficult to insert 75
Self-activation or keying 69
Maintenance does not comply to manufacturers recommendations 67
Human-Device Interface Issue 63
Material deformation 63
Size incorrect for patient 62
Material frayed 62
Failure to power-up 60
Material separation 59
Sticking 58
Suspect EMI 57
Difficult to remove 53
Loose or intermittent connection 53
Shock, electrical 52
Tipover 49
Component(s), broken 48
Battery failure 44
Loss of Data 44
Foreign material present in device 43
No code available 42
Lead(s), fracture of 42
Device Issue 41
Defective component 41
Slippage of device or device component 41
Total Device Problems 95464

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 2 3 2 2 2 4 5 1 1 5 0
Class III 1 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Bionics Corp III Mar-31-2007
2 Advanced Bionics Corp II Oct-31-2008
3 Advanced Bionics Corp II Feb-27-2008
4 Advanced Bionics Corp II Oct-12-2007
5 Advanced Bionics Corporation II Apr-19-2012
6 Advanced Bionics Corporation II Jan-10-2007
7 Advanced Neuromodulation Systems II Aug-30-2011
8 Advanced Neuromodulation Systems Inc. II Oct-09-2012
9 Advanced Neuromodulation Systems Inc. II Aug-28-2012
10 Advanced Neuromodulation Systems Inc. II Jul-10-2012
11 Advanced Neuromodulation Systems Inc. II Jun-22-2011
12 Advanced Neuromodulation Systems, Inc II May-13-2010
13 Advanced Neuromodulation Systems, Inc II Nov-10-2009
14 Boston Scientific Neuromodulation Corporation II Apr-16-2010
15 Medtronic Neuromodulation II Jun-07-2016
16 Medtronic Neuromodulation II Feb-23-2016
17 Medtronic Neuromodulation II Jun-26-2015
18 Medtronic Neuromodulation II Apr-29-2014
19 Medtronic Neuromodulation II Nov-14-2013
20 Medtronic Neuromodulation II Oct-31-2013
21 Medtronic Neuromodulation II Dec-11-2009
22 Medtronic Neuromodulation III Sep-20-2008
23 Medtronic Neuromodulation II Sep-16-2008
24 Nuvectra II Dec-17-2016
25 Nuvectra II May-03-2016
26 QiG Group LLC II Mar-18-2016
27 St. Jude Medical II Jul-31-2013
28 St. Jude Medical II Jul-22-2013
29 St. Jude Medical II Jul-16-2013

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