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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 12

Device Problems
Device operates differently than expected 13570
No Known Device Problem 10300
Temperature issue 5040
Migration of device or device component 4717
Charging issue 4593
Communication or transmission issue 4196
High impedance 4189
Inappropriate shock 2821
Not Applicable 2754
Impedance issue 2432
Failure to deliver energy 2226
Device displays error message 1916
Failure to charge 1816
Positioning Issue 1578
Therapy delivered to incorrect body area 1528
Low battery 1515
No device output 1496
Battery issue 1470
Use of Device Issue 1425
No Information 1225
Fracture 1191
Intermittent continuity 1037
Failure to interrogate 1012
Malposition of device 885
Break 836
Unintended collision 827
Premature discharge of battery 793
Replace 789
Device inoperable 787
Explanted 762
Improper or incorrect procedure or method 749
Low impedance 706
Unintended movement 600
Device remains implanted 586
Connection issue 566
Electro-magnetic interference (EMI) 540
Delayed charge time 502
Implant, reprogramming of 470
Unknown (for use when the device problem is not known) 441
Device stops intermittently 427
Overheating of device or device component 416
Electromagnetic compatibility issue 398
Disconnection 397
Device remains activated 384
Material integrity issue 346
Unstable 322
Output issue 307
Telemetry discrepancy 288
Kinked 268
Electronic property issue 262
Pocket stimulation 258
Unexpected therapeutic results 212
Energy output to patient tissue incorrect 210
Dislodged 187
Difficult to advance 181
Premature end-of-life indicator 179
Implant, repositioning of 177
Dislodged or dislocated 177
Unit inactivated 170
Bent 170
Malfunction 147
Improper device output 142
Device or device fragments location unknown 138
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 91
No telemetry 88
Incorrect display 84
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 62
Material deformation 61
Size incorrect for patient 60
Material frayed 60
Material separation 59
Failure to power-up 59
Sticking 58
Suspect EMI 57
Loose or intermittent connection 53
Shock, electrical 52
Difficult to remove 50
Tipover 49
Component(s), broken 48
Battery failure 44
Foreign material present in device 43
Loss of Data 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 93658

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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