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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
20 53 38 56 47 68 22

Device Problems
Device operates differently than expected 6592
No Known Device Problem 4968
Temperature issue 3027
Migration of device or device component 2564
High impedance 2299
Not Applicable 1896
Communication or transmission issue 1831
Inappropriate shock 1759
Impedance issue 1740
Charging issue 1552
Positioning Issue 1242
Failure to charge 1033
No Information 950
No device output 842
Replace 786
Explanted 761
Use of Device Issue 735
Therapy delivered to incorrect body area 664
Fracture 657
Premature discharge of battery 599
Device remains implanted 585
Low battery 492
Implant, reprogramming of 467
Low impedance 451
Unknown (for use when the device problem is not known) 441
Device inoperable 439
Unintended movement 430
Intermittent continuity 405
Device stops intermittently 384
Device remains activated 380
Electro-magnetic interference (EMI) 319
Output issue 307
Electronic property issue 259
Battery issue 244
Device displays error message 240
Break 225
Malposition of device 215
Disconnection 214
Dislodged 187
Implant, repositioning of 177
Telemetry discrepancy 171
Unit inactivated 169
Premature end-of-life indicator 148
Malfunction 147
Device operational issue 146
Failure to interrogate 142
Circuit breaker tripped 136
Connection issue 133
Dislodged or dislocated 129
Loss of power 127
Pocket stimulation 115
Improper or incorrect procedure or method 113
Other (for use when an appropriate device code cannot be identified) 109
Lead(s), breakage of 108
Difficult to advance 105
Delayed charge time 100
Detachment of device component 95
Electro-magnetic interference (EMI), compatibility/incompatibility 93
No telemetry 87
Difficult to position 86
Kinked 85
Repair 83
Wire(s), breakage of 80
Unexpected therapeutic results 71
Detachment of device or device component 68
Maintenance does not comply to manufacturers recommendations 64
Suspect EMI 57
Shock, electrical 52
Self-activation or keying 50
Tipover 48
Component(s), broken 47
Difficult to Program or Calibrate 46
Loose or intermittent connection 45
Bent 45
Battery failure 44
Material separation 42
Lead(s), fracture of 42
Slippage of device or device component 40
Defective component 38
Fitting problem 36
Electromagnetic compatibility issue 36
Device, or device fragments remain in patient 36
Intermittent shock 35
Difficult to insert 35
Material erosion 32
Sticking 32
Device Issue 32
Couple, failure to 31
No code available 31
Failure to shut off 30
Improper device output 30
Material frayed 29
Inappropriate or unexpected reset 29
Mechanical issue 28
Overheating of device or device component 27
Output above specifications 27
Program, failure to 27
Size incorrect for patient 26
Difficult to interrogate 25
Electrical shorting 25
Total Device Problems 47503

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 2 3 2 2 2 4 0
Class III 1 1 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 Dec-11-2009
16 Medtronic Neuromodulation III Sep-20-2008
17 Medtronic Neuromodulation II Sep-16-2008

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