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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 0

Device Problems
Device operates differently than expected 13231
No Known Device Problem 10029
Temperature issue 5040
Migration of device or device component 4604
Charging issue 4363
Communication or transmission issue 4077
High impedance 4070
Inappropriate shock 2752
Not Applicable 2745
Impedance issue 2419
Failure to deliver energy 2059
Failure to charge 1804
Device displays error message 1801
Positioning Issue 1561
Therapy delivered to incorrect body area 1484
No device output 1478
Use of Device Issue 1420
Low battery 1420
Battery issue 1354
No Information 1225
Fracture 1174
Intermittent continuity 995
Failure to interrogate 933
Malposition of device 839
Break 799
Replace 789
Premature discharge of battery 784
Explanted 762
Device inoperable 759
Unintended collision 750
Low impedance 700
Improper or incorrect procedure or method 683
Unintended movement 600
Device remains implanted 586
Connection issue 537
Electro-magnetic interference (EMI) 524
Implant, reprogramming of 470
Delayed charge time 460
Unknown (for use when the device problem is not known) 441
Device stops intermittently 427
Disconnection 392
Overheating of device or device component 390
Device remains activated 384
Electromagnetic compatibility issue 364
Material integrity issue 323
Output issue 307
Unstable 294
Telemetry discrepancy 284
Kinked 267
Electronic property issue 262
Pocket stimulation 251
Unexpected therapeutic results 203
Energy output to patient tissue incorrect 195
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 138
Circuit breaker tripped 137
Loss of power 130
Device or device fragments location unknown 124
Detachment of device component 111
Other (for use when an appropriate device code cannot be identified) 109
Lead(s), breakage of 108
Detachment of device or device component 108
Difficult to Program or Calibrate 100
Electro-magnetic interference (EMI), compatibility/incompatibility 94
Difficult to position 90
No telemetry 88
Repair 83
Incorrect display 83
Wire(s), breakage of 80
Difficult to insert 74
Self-activation or keying 69
Maintenance does not comply to manufacturers recommendations 67
Material deformation 59
Size incorrect for patient 59
Material frayed 59
Sticking 58
Material separation 58
Suspect EMI 57
Failure to power-up 56
Human-Device Interface Issue 55
Loose or intermittent connection 53
Shock, electrical 52
Difficult to remove 50
Tipover 49
Component(s), broken 48
Battery failure 44
Lead(s), fracture of 42
Foreign material present in device 42
No code available 42
Defective component 41
Slippage of device or device component 41
Fitting problem 39
Cut in material 39
Total Device Problems 91088

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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