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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 39

MDR Year MDR Reports MDR Events
2016 15639 15639
2017 18605 18605
2018 23623 23623
2019 30039 30039
2020 28104 28104
2021 12548 12548

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34904 34904
Charging Problem 15737 15737
High impedance 10985 10985
Battery Problem 9745 9745
Device Operates Differently Than Expected 9347 9347
Insufficient Information 8737 8737
Failure to Deliver Energy 7352 7352
Communication or Transmission Problem 6266 6266
Migration 6187 6187
Therapeutic or Diagnostic Output Failure 6140 6140
Migration or Expulsion of Device 5950 5950
Improper or Incorrect Procedure or Method 5163 5163
Unexpected Therapeutic Results 5031 5031
Use of Device Problem 4176 4176
Inappropriate/Inadequate Shock/Stimulation 4132 4132
Unintended Collision 3772 3772
Premature Elective Replacement Indicator 3540 3540
Wireless Communication Problem 3510 3510
Device Displays Incorrect Message 3507 3507
Failure to Interrogate 3209 3209
Energy Output Problem 3062 3062
Delayed Charge Time 2509 2509
No Device Output 2440 2440
Intermittent Continuity 2317 2317
Low Battery 2096 2096
Therapy Delivered to Incorrect Body Area 2093 2093
Overheating of Device 2089 2089
Malposition of Device 1935 1935
Impedance Problem 1922 1922
Break 1913 1913
Fracture 1903 1903
Device Inoperable 1680 1680
Patient Device Interaction Problem 1546 1546
Premature Discharge of Battery 1544 1544
Connection Problem 1472 1472
Electromagnetic Compatibility Problem 1306 1306
Unstable 1066 1066
Material Integrity Problem 1011 1011
Low impedance 987 987
Positioning Problem 984 984
Electromagnetic Interference 914 914
Failure to Charge 836 836
No Apparent Adverse Event 741 741
Defective Device 698 698
Application Program Freezes, Becomes Nonfunctional 658 658
Disconnection 620 620
Display or Visual Feedback Problem 539 539
Patient-Device Incompatibility 492 492
Nonstandard Device 439 439
Energy Output To Patient Tissue Incorrect 386 386
Data Problem 373 373
Device Or Device Fragments Location Unknown 312 312
Pocket Stimulation 294 294
Temperature Problem 269 269
Material Deformation 231 231
Improper Device Output 219 219
Device Difficult to Program or Calibrate 215 215
Failure to Power Up 213 213
Loss of Data 196 196
Appropriate Term/Code Not Available 187 187
Device Dislodged or Dislocated 183 183
Premature End-of-Life Indicator 172 172
Difficult to Remove 163 163
Shipping Damage or Problem 157 157
Difficult to Insert 135 135
Human-Device Interface Problem 134 134
Environmental Compatibility Problem 130 130
Telemetry Discrepancy 113 113
Device Contamination with Chemical or Other Material 104 104
Unable to Obtain Readings 99 99
Detachment of Device or Device Component 93 93
Device Stops Intermittently 92 92
Material Frayed 90 90
Inadequacy of Device Shape and/or Size 89 89
Unexpected Shutdown 86 86
Intermittent Energy Output 85 85
Material Separation 82 82
Material Twisted/Bent 81 81
Bent 80 80
Material Split, Cut or Torn 79 79
Kinked 78 78
Material Fragmentation 74 74
Inadequate Instructions for Non-Healthcare Professional 65 65
Material Protrusion/Extrusion 63 63
Component Missing 62 62
Unintended Movement 55 55
Power Problem 48 48
Application Program Problem 48 48
Electro-Static Discharge 46 46
Vibration 44 44
Degraded 44 44
Loss of Power 43 43
Device Damaged by Another Device 41 41
Noise, Audible 39 39
Mechanical Problem 37 37
Failure to Fire 29 29
Ambient Noise Problem 29 29
Defective Component 26 26
Self-Activation or Keying 26 26
Operating System Becomes Nonfunctional 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 33439 33439
No Known Impact Or Consequence To Patient 22594 22596
Pain 20406 20409
Therapeutic Effects, Unexpected 14062 14068
No Code Available 12360 12360
Discomfort 7671 7671
Unspecified Infection 5145 5147
No Consequences Or Impact To Patient 5086 5087
Therapeutic Response, Decreased 4608 4609
No Clinical Signs, Symptoms or Conditions 4580 4580
Complaint, Ill-Defined 4163 4164
Undesired Nerve Stimulation 3590 3590
Electric Shock 3519 3519
Burning Sensation 2874 2874
Device Overstimulation of Tissue 2008 2008
Post Operative Wound Infection 1815 1815
Bacterial Infection 1579 1579
Ambulation Difficulties 1320 1320
No Information 1312 1312
Swelling 1188 1188
Fall 1004 1004
Numbness 970 970
Insufficient Information 957 957
Wound Dehiscence 866 866
Fluid Discharge 827 827
Erosion 825 825
Hematoma 753 753
Cerebrospinal Fluid Leakage 747 747
Headache 726 726
Scar Tissue 657 658
Weight Changes 623 623
Tingling 613 613
Impaired Healing 611 611
Fever 583 583
Death 575 575
Muscle Spasm(s) 550 550
Failure of Implant 525 525
Erythema 521 521
Paralysis 511 511
Sleep Dysfunction 466 466
Irritation 462 462
Staphylococcus Aureus 452 452
Implant Pain 450 450
Purulent Discharge 408 408
Burn(s) 379 379
Muscle Weakness 354 354
Weakness 352 352
Seroma 348 348
Hypersensitivity/Allergic reaction 317 317
Discharge 309 309
Nausea 304 304
Inflammation 300 300
Device Embedded In Tissue or Plaque 292 292
Bruise/Contusion 289 289
Pocket Erosion 287 287
Skin Erosion 232 232
Itching Sensation 222 222
Abdominal Pain 218 218
Seizures 212 212
Alteration In Body Temperature 204 204
Abscess 201 201
Malaise 196 196
Anxiety 184 184
Nerve Damage 184 184
Neurological Deficit/Dysfunction 183 183
Rash 179 179
Hemorrhage/Bleeding 175 175
Shaking/Tremors 175 175
Distress 173 173
Incontinence 163 163
Neuropathy 159 159
Vomiting 158 158
Cramp(s) 155 155
Neck Pain 150 150
Cognitive Changes 147 147
Muscular Rigidity 140 140
Headache, Lumbar Puncture 136 136
Stroke/CVA 133 133
Dyspnea 125 125
Injury 114 114
Dizziness 112 112
Sepsis 111 111
Chest Pain 109 109
Foreign Body Reaction 109 109
Swelling/ Edema 108 108
Twitching 90 90
Edema 89 89
Irritability 87 87
Skin Irritation 87 87
Urinary Retention 86 87
High Blood Pressure/ Hypertension 83 83
Loss of consciousness 79 79
Skin Inflammation 79 79
Spinal Cord Injury 79 79
Respiratory Distress 79 79
Reaction 79 79
Loss of Range of Motion 78 78
Chills 78 78
Depression 76 76
Patient Problem/Medical Problem 76 76

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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