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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 48

Device Problems
Device operates differently than expected 14779
No Known Device Problem 11657
Charging issue 5484
Migration of device or device component 5080
Temperature issue 5045
Communication or transmission issue 4648
High impedance 4567
Inappropriate shock 3064
Not Applicable 2794
Failure to deliver energy 2769
Impedance issue 2501
Device displays error message 2320
Failure to charge 1896
Battery issue 1866
Low battery 1813
Therapy delivered to incorrect body area 1694
Use of Device Issue 1653
Positioning Issue 1638
No device output 1618
Fracture 1254
Failure to interrogate 1238
No Information 1226
Intermittent continuity 1200
Unintended collision 1065
Malposition of device 1016
Device inoperable 1008
Improper or incorrect procedure or method 963
Break 958
Premature discharge of battery 823
Replace 789
Explanted 762
Low impedance 741
Connection issue 648
Delayed charge time 634
Unintended movement 600
Electro-magnetic interference (EMI) 593
Device remains implanted 587
Overheating of device or device component 526
Electromagnetic compatibility issue 487
Implant, reprogramming of 471
Unknown (for use when the device problem is not known) 441
Device stops intermittently 433
Material integrity issue 412
Disconnection 409
Unstable 391
Device remains activated 384
Output issue 307
Telemetry discrepancy 303
Kinked 282
Pocket stimulation 276
Electronic property issue 262
Energy output to patient tissue incorrect 249
Unexpected therapeutic results 247
Dislodged 187
Bent 187
Premature end-of-life indicator 181
Difficult to advance 181
Dislodged or dislocated 178
Implant, repositioning of 177
Device or device fragments location unknown 173
Improper device output 172
Unit inactivated 170
Malfunction 147
Circuit breaker tripped 137
Loss of power 130
Difficult to Program or Calibrate 111
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
Incorrect display 107
Electro-magnetic interference (EMI), compatibility/incompatibility 94
Difficult to position 92
No telemetry 88
Repair 83
Material deformation 82
Wire(s), breakage of 80
Difficult to insert 79
Human-Device Interface Issue 71
Self-activation or keying 69
Size incorrect for patient 67
Maintenance does not comply to manufacturers recommendations 67
Material frayed 66
Failure to power-up 65
Material separation 62
Sticking 58
Difficult to remove 57
Suspect EMI 57
Loose or intermittent connection 54
Loss of Data 53
Shock, electrical 52
Tipover 49
Component(s), broken 48
Foreign material present in device 48
Inadequate instructions for non-healthcare professional 45
Battery failure 44
Defective component 44
No code available 43
Device Issue 42
Unable to obtain readings 42
Total Device Problems 103349

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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