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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
38 56 47 68 71 68 72 92 94 64 69 52 56 60 63 61

MDR Year MDR Reports MDR Events
2014 11251 11251
2015 11689 11689
2016 15641 15641
2017 18607 18607
2018 23626 23626
2019 30039 30039
2020 28106 28106
2021 24333 24333
2022 23272 23272
2023 33527 33527
2024 24663 24664

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 56276 56276
Charging Problem 31517 31517
High impedance 23788 23788
Battery Problem 23023 23023
Insufficient Information 16657 16657
Device Operates Differently Than Expected 15296 15296
Migration 15166 15167
Failure to Deliver Energy 13132 13132
Communication or Transmission Problem 12621 12621
Unexpected Therapeutic Results 11224 11224
Migration or Expulsion of Device 10811 10811
Overheating of Device 10390 10390
Therapeutic or Diagnostic Output Failure 10064 10064
Wireless Communication Problem 9397 9397
Improper or Incorrect Procedure or Method 8386 8386
Inappropriate/Inadequate Shock/Stimulation 8119 8119
Failure to Interrogate 6715 6715
Unintended Collision 5979 5979
Device Displays Incorrect Message 5497 5497
Connection Problem 5357 5357
Delayed Charge Time 5177 5177
Energy Output Problem 5108 5108
Use of Device Problem 4766 4766
Fracture 4443 4443
Intermittent Continuity 4100 4100
Break 3844 3844
Therapy Delivered to Incorrect Body Area 3730 3730
Premature Elective Replacement Indicator 3652 3652
No Apparent Adverse Event 3508 3508
Impedance Problem 3496 3496
Malposition of Device 3319 3319
Low Battery 3292 3292
Material Integrity Problem 3116 3116
Failure to Power Up 2917 2917
No Device Output 2882 2882
Positioning Problem 2789 2789
Display or Visual Feedback Problem 2702 2702
Patient Device Interaction Problem 2455 2455
Premature Discharge of Battery 2364 2364
Electromagnetic Compatibility Problem 2269 2269
Failure to Charge 1992 1992
Device Inoperable 1881 1881
Unstable 1790 1790
Low impedance 1688 1688
Defective Device 1670 1670
Electromagnetic Interference 1426 1426
Operating System Becomes Nonfunctional 1060 1060
Disconnection 984 984
Data Problem 888 888
Application Program Problem 718 718

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 65574 65575
No Clinical Signs, Symptoms or Conditions 37868 37868
Pain 35780 35783
No Known Impact Or Consequence To Patient 27339 27341
Therapeutic Effects, Unexpected 20139 20145
No Code Available 12494 12494
Discomfort 12209 12209
Unspecified Infection 8862 8864
Failure of Implant 7352 7352
Undesired Nerve Stimulation 7022 7022
Electric Shock 6731 6731
Burning Sensation 6458 6458
Therapeutic Response, Decreased 6398 6399
No Consequences Or Impact To Patient 6058 6059
Insufficient Information 5869 5869
Complaint, Ill-Defined 5775 5776
Implant Pain 5487 5487
Device Overstimulation of Tissue 3212 3212
Bacterial Infection 3098 3098
Post Operative Wound Infection 3020 3020
Ambulation Difficulties 2204 2204
No Information 1827 1827
Wound Dehiscence 1706 1706
Swelling 1682 1682
Numbness 1679 1679
Fluid Discharge 1597 1597
Erosion 1386 1386
Fall 1370 1370
Hematoma 1338 1338
Headache 1322 1322
Cerebrospinal Fluid Leakage 1253 1253
Impaired Healing 1180 1180
Scar Tissue 1100 1101
Fever 1029 1029
Erythema 987 987
Paralysis 875 875
Muscle Weakness 847 847
Purulent Discharge 816 816
Tingling 815 815
Burn(s) 764 764
Sleep Dysfunction 760 760
Weight Changes 753 753
Muscle Spasm(s) 750 750
Swelling/ Edema 742 742
Staphylococcus Aureus 674 674
Pocket Erosion 633 633
Death 622 622
Hypersensitivity/Allergic reaction 612 612
Irritation 600 600
Seroma 581 581

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-16-2024
2 Abbott Medical I Sep-11-2023
3 Advanced Bionics Corporation II Apr-19-2012
4 Advanced Neuromodulation Systems II Aug-30-2011
5 Advanced Neuromodulation Systems Inc. II Oct-09-2012
6 Advanced Neuromodulation Systems Inc. II Aug-28-2012
7 Advanced Neuromodulation Systems Inc. II Jul-10-2012
8 Advanced Neuromodulation Systems Inc. II Jun-22-2011
9 Advanced Neuromodulation Systems, Inc II May-13-2010
10 Advanced Neuromodulation Systems, Inc II Nov-10-2009
11 Boston Scientific Neuromodulation Corporation II Aug-14-2024
12 Boston Scientific Neuromodulation Corporation II May-26-2020
13 Boston Scientific Neuromodulation Corporation II Apr-16-2010
14 Medtronic Neuromodulation II Apr-26-2024
15 Medtronic Neuromodulation II Jan-22-2024
16 Medtronic Neuromodulation II Nov-20-2023
17 Medtronic Neuromodulation II Sep-29-2023
18 Medtronic Neuromodulation II Jul-21-2023
19 Medtronic Neuromodulation II Jun-29-2023
20 Medtronic Neuromodulation II Jan-06-2023
21 Medtronic Neuromodulation II Aug-25-2022
22 Medtronic Neuromodulation II Aug-24-2022
23 Medtronic Neuromodulation II May-23-2022
24 Medtronic Neuromodulation II Nov-24-2021
25 Medtronic Neuromodulation II Jul-28-2021
26 Medtronic Neuromodulation II May-06-2021
27 Medtronic Neuromodulation II Jan-14-2021
28 Medtronic Neuromodulation II Jul-13-2018
29 Medtronic Neuromodulation II Jun-07-2016
30 Medtronic Neuromodulation II Feb-23-2016
31 Medtronic Neuromodulation II Jun-26-2015
32 Medtronic Neuromodulation II Apr-29-2014
33 Medtronic Neuromodulation II Nov-14-2013
34 Medtronic Neuromodulation II Oct-31-2013
35 Medtronic Neuromodulation II Dec-11-2009
36 Nuvectra II Dec-17-2016
37 Nuvectra II May-03-2016
38 QiG Group LLC II Mar-18-2016
39 St. Jude Medical II Jul-31-2013
40 St. Jude Medical II Jul-22-2013
41 St. Jude Medical II Jul-16-2013
42 St. Jude Medical, Inc. II Oct-17-2017
43 St. Jude Medical, Inc. II Jul-07-2017
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