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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)
2016 2017 2018 2019 2020 2021
92 94 64 69 52 46

MDR Year MDR Reports MDR Events
2016 15639 15639
2017 18605 18605
2018 23623 23623
2019 30039 30039
2020 28105 28105
2021 18185 18185

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36169 36169
Charging Problem 16285 16285
High impedance 11652 11652
Battery Problem 10471 10471
Device Operates Differently Than Expected 9347 9347
Insufficient Information 8996 8996
Failure to Deliver Energy 7511 7511
Migration 6847 6847
Therapeutic or Diagnostic Output Failure 6441 6441
Communication or Transmission Problem 6374 6374
Migration or Expulsion of Device 6119 6119
Unexpected Therapeutic Results 5475 5475
Improper or Incorrect Procedure or Method 5420 5420
Inappropriate/Inadequate Shock/Stimulation 4284 4284
Use of Device Problem 4197 4197
Wireless Communication Problem 3896 3896
Unintended Collision 3867 3867
Premature Elective Replacement Indicator 3568 3568
Device Displays Incorrect Message 3507 3507
Failure to Interrogate 3286 3286
Energy Output Problem 3180 3180
Delayed Charge Time 2614 2614
No Device Output 2459 2459
Intermittent Continuity 2382 2382
Overheating of Device 2160 2160
Therapy Delivered to Incorrect Body Area 2123 2123
Low Battery 2096 2096
Fracture 2081 2081
Impedance Problem 2020 2020
Malposition of Device 1976 1976
Break 1975 1975
Device Inoperable 1680 1680
Patient Device Interaction Problem 1597 1597
Premature Discharge of Battery 1585 1585
Connection Problem 1498 1498
Electromagnetic Compatibility Problem 1329 1329
Unstable 1095 1095
Low impedance 1031 1031
Material Integrity Problem 1016 1016
Positioning Problem 1016 1016
Electromagnetic Interference 935 935
Failure to Charge 837 837
Defective Device 780 780
No Apparent Adverse Event 776 776
Application Program Freezes, Becomes Nonfunctional 660 660
Disconnection 642 642
Display or Visual Feedback Problem 558 558
Patient-Device Incompatibility 496 496
Nonstandard Device 439 439
Data Problem 405 405
Energy Output To Patient Tissue Incorrect 386 386
Device Or Device Fragments Location Unknown 312 312
Pocket Stimulation 307 307
Temperature Problem 285 285
Material Deformation 240 240
Improper Device Output 219 219
Device Difficult to Program or Calibrate 219 219
Failure to Power Up 215 215
Loss of Data 201 201
Appropriate Term/Code Not Available 191 191
Device Dislodged or Dislocated 186 186
Premature End-of-Life Indicator 172 172
Difficult to Remove 167 167
Shipping Damage or Problem 157 157
Difficult to Insert 140 140
Human-Device Interface Problem 136 136
Environmental Compatibility Problem 131 131
Telemetry Discrepancy 113 113
Device Contamination with Chemical or Other Material 106 106
Unable to Obtain Readings 99 99
Detachment of Device or Device Component 94 94
Material Frayed 92 92
Device Stops Intermittently 92 92
Intermittent Energy Output 91 91
Inadequacy of Device Shape and/or Size 89 89
Unexpected Shutdown 87 87
Material Twisted/Bent 87 87
Application Program Problem 85 85
Material Separation 82 82
Bent 80 80
Material Split, Cut or Torn 80 80
Kinked 78 78
Material Fragmentation 76 76
Inadequate Instructions for Non-Healthcare Professional 65 65
Component Missing 64 64
Material Protrusion/Extrusion 63 63
Unintended Movement 55 55
Power Problem 51 51
Electro-Static Discharge 48 48
Degraded 46 46
Vibration 45 45
Loss of Power 43 43
Device Damaged by Another Device 42 42
Noise, Audible 39 39
Mechanical Problem 37 37
Failure to Fire 29 29
Ambient Noise Problem 29 29
Operating System Becomes Nonfunctional 27 27
Defective Component 26 26
Self-Activation or Keying 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 35959 35959
No Known Impact Or Consequence To Patient 22594 22596
Pain 20831 20834
Therapeutic Effects, Unexpected 14062 14068
No Code Available 12361 12361
Discomfort 7835 7835
No Clinical Signs, Symptoms or Conditions 6161 6161
Unspecified Infection 5341 5343
No Consequences Or Impact To Patient 5086 5087
Therapeutic Response, Decreased 4608 4609
Complaint, Ill-Defined 4163 4164
Undesired Nerve Stimulation 3760 3760
Electric Shock 3617 3617
Burning Sensation 2960 2960
Device Overstimulation of Tissue 2036 2036
Post Operative Wound Infection 1896 1896
Bacterial Infection 1646 1646
Ambulation Difficulties 1351 1351
No Information 1312 1312
Insufficient Information 1265 1265
Swelling 1188 1188
Fall 1018 1018
Numbness 1003 1003
Wound Dehiscence 903 903
Fluid Discharge 861 861
Erosion 854 854
Hematoma 791 791
Cerebrospinal Fluid Leakage 788 788
Headache 754 754
Implant Pain 725 725
Scar Tissue 667 668
Impaired Healing 638 638
Weight Changes 629 629
Tingling 613 613
Failure of Implant 612 612
Fever 602 602
Death 575 575
Muscle Spasm(s) 550 550
Paralysis 533 533
Erythema 530 530
Sleep Dysfunction 476 476
Irritation 462 462
Staphylococcus Aureus 452 452
Purulent Discharge 421 421
Burn(s) 406 406
Muscle Weakness 382 382
Seroma 366 366
Weakness 352 352
Hypersensitivity/Allergic reaction 333 333
Nausea 314 314
Discharge 309 309
Inflammation 305 305
Pocket Erosion 298 298
Device Embedded In Tissue or Plaque 298 298
Bruise/Contusion 295 295
Skin Erosion 239 239
Itching Sensation 226 226
Abdominal Pain 223 223
Seizures 212 212
Abscess 205 205
Alteration In Body Temperature 204 204
Malaise 199 199
Nerve Damage 192 192
Anxiety 189 189
Hemorrhage/Bleeding 183 183
Shaking/Tremors 183 183
Neurological Deficit/Dysfunction 183 183
Rash 182 182
Distress 175 175
Vomiting 168 168
Incontinence 166 166
Neuropathy 162 162
Neck Pain 156 156
Cramp(s) 155 155
Cognitive Changes 149 149
Swelling/ Edema 145 145
Stroke/CVA 142 142
Muscular Rigidity 141 141
Headache, Lumbar Puncture 136 136
Dyspnea 129 129
Dizziness 118 118
Sepsis 115 115
Injury 114 114
Chest Pain 114 114
Foreign Body Reaction 113 113
Twitching 91 91
Urinary Retention 90 91
Edema 89 89
High Blood Pressure/ Hypertension 89 89
Skin Irritation 87 87
Irritability 87 87
Loss of Range of Motion 82 82
Cramp(s) /Muscle Spasm(s) 82 82
Loss of consciousness 81 81
Spinal Cord Injury 81 81
Skin Inflammation 79 79
Chills 79 79
Reaction 79 79
Respiratory Distress 79 79
Depression 78 78

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
2 Medtronic Neuromodulation II Jul-28-2021
3 Medtronic Neuromodulation II May-06-2021
4 Medtronic Neuromodulation II Jan-14-2021
5 Medtronic Neuromodulation II Jul-13-2018
6 Medtronic Neuromodulation II Jun-07-2016
7 Medtronic Neuromodulation II Feb-23-2016
8 Nuvectra II Dec-17-2016
9 Nuvectra II May-03-2016
10 QiG Group LLC II Mar-18-2016
11 St. Jude Medical, Inc. II Oct-17-2017
12 St. Jude Medical, Inc. II Jul-07-2017
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