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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)
2018 2019 2020 2021 2022 2023
64 69 52 56 60 4

MDR Year MDR Reports MDR Events
2018 23625 23625
2019 30039 30039
2020 28105 28105
2021 24336 24336
2022 23279 23279

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 33386 33386
Charging Problem 13895 13895
High impedance 12662 12662
Battery Problem 11796 11796
Insufficient Information 10280 10280
Migration 10156 10156
Therapeutic or Diagnostic Output Failure 7923 7923
Unexpected Therapeutic Results 7548 7548
Wireless Communication Problem 6035 6035
Improper or Incorrect Procedure or Method 5379 5379
Failure to Deliver Energy 4959 4959
Migration or Expulsion of Device 4492 4492
Communication or Transmission Problem 3948 3948
Inappropriate/Inadequate Shock/Stimulation 3700 3700
Energy Output Problem 3685 3685
Premature Elective Replacement Indicator 2986 2986
Unintended Collision 2857 2857
Fracture 2645 2645
Use of Device Problem 2469 2469
Failure to Interrogate 2308 2308
Delayed Charge Time 2273 2273
Impedance Problem 2185 2185
Device Operates Differently Than Expected 2113 2113
Overheating of Device 1917 1917
Patient Device Interaction Problem 1863 1863
Intermittent Continuity 1702 1702
No Device Output 1665 1665
Break 1551 1551
Premature Discharge of Battery 1533 1533
Therapy Delivered to Incorrect Body Area 1325 1325
Malposition of Device 1264 1264
Defective Device 1118 1118
Low impedance 1024 1024
Electromagnetic Compatibility Problem 937 937
Connection Problem 887 887
Device Displays Incorrect Message 885 885
Positioning Problem 831 831
Unstable 764 764
Application Program Freezes, Becomes Nonfunctional 660 660
Electromagnetic Interference 641 641
Disconnection 546 546
Data Problem 534 534
Patient-Device Incompatibility 510 510
Display or Visual Feedback Problem 508 508
Low Battery 495 495
No Apparent Adverse Event 439 439
Material Integrity Problem 439 439
Device Inoperable 393 393
Failure to Charge 342 342
Application Program Problem 327 327
Temperature Problem 263 263
Device Dislodged or Dislocated 208 208
Pocket Stimulation 189 189
Appropriate Term/Code Not Available 182 182
Failure to Power Up 168 168
Difficult to Remove 161 161
Loss of Data 161 161
Material Deformation 159 159
Device Difficult to Program or Calibrate 153 153
Premature End-of-Life Indicator 153 153
Material Twisted/Bent 129 129
Intermittent Energy Output 121 121
Material Fragmentation 118 118
Difficult to Insert 110 110
Unexpected Shutdown 103 103
Human-Device Interface Problem 103 103
Material Split, Cut or Torn 100 100
Device Or Device Fragments Location Unknown 96 96
Shipping Damage or Problem 93 93
Environmental Compatibility Problem 85 85
Energy Output To Patient Tissue Incorrect 79 79
Detachment of Device or Device Component 73 73
Device Contamination with Chemical or Other Material 71 71
Material Frayed 65 65
Unintended Movement 54 54
Power Problem 53 53
Degraded 53 53
Unable to Obtain Readings 52 52
Inadequacy of Device Shape and/or Size 51 51
Material Separation 48 48
Material Protrusion/Extrusion 45 45
Device Damaged by Another Device 44 44
Loss of Power 41 41
Mechanical Problem 40 40
Improper Device Output 35 35
Failure to Disconnect 30 30
Failure to Fire 29 29
Electro-Static Discharge 29 29
Component Missing 27 27
Computer Software Problem 27 27
Operating System Becomes Nonfunctional 27 27
Vibration 26 26
Noise, Audible 25 25
Output Problem 22 22
Entrapment of Device 21 21
Telemetry Discrepancy 19 19
Ambient Noise Problem 19 19
Inadequate Instructions for Non-Healthcare Professional 19 19
Failure to Advance 18 18
Structural Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 44433 44433
Pain 15066 15069
No Clinical Signs, Symptoms or Conditions 14216 14216
No Known Impact Or Consequence To Patient 13548 13550
No Code Available 12222 12222
Therapeutic Effects, Unexpected 7399 7405
Discomfort 5838 5838
No Consequences Or Impact To Patient 5077 5078
Unspecified Infection 4880 4881
Undesired Nerve Stimulation 3250 3250
Insufficient Information 2874 2874
Electric Shock 2752 2752
Therapeutic Response, Decreased 2336 2337
Burning Sensation 2333 2333
Implant Pain 2298 2298
Complaint, Ill-Defined 2135 2136
Post Operative Wound Infection 1726 1726
Failure of Implant 1721 1721
Device Overstimulation of Tissue 1235 1235
Bacterial Infection 1192 1192
Wound Dehiscence 879 879
Cerebrospinal Fluid Leakage 861 861
Ambulation Difficulties 861 861
Fluid Discharge 860 860
Numbness 822 822
Erosion 785 785
Fall 771 771
Hematoma 735 735
Swelling 650 650
Headache 638 638
Impaired Healing 559 559
Scar Tissue 481 482
Burn(s) 465 465
Fever 452 452
Paralysis 443 443
Death 437 437
Muscle Weakness 414 414
No Information 377 377
Swelling/ Edema 367 367
Weight Changes 364 364
Erythema 363 363
Purulent Discharge 337 337
Tingling 328 328
Sleep Dysfunction 319 319
Pocket Erosion 306 306
Hypersensitivity/Allergic reaction 298 298
Muscle Spasm(s) 291 291
Seroma 282 282
Staphylococcus Aureus 264 264
Device Embedded In Tissue or Plaque 254 254
Nausea 252 252
Irritation 238 238
Inflammation 234 234
Weakness 219 219
Bruise/Contusion 198 198
Abdominal Pain 183 183
Itching Sensation 183 183
Cramp(s) /Muscle Spasm(s) 179 179
Hemorrhage/Bleeding 173 173
Skin Inflammation/ Irritation 169 169
Abscess 163 163
Skin Erosion 155 155
Paresthesia 151 151
Rash 145 145
Stroke/CVA 142 142
Vomiting 140 140
Neurological Deficit/Dysfunction 138 138
Anxiety 133 133
Nerve Damage 127 127
Incontinence 124 124
Headache, Lumbar Puncture 115 115
Seizures 113 113
Alteration In Body Temperature 109 109
Shaking/Tremors 109 109
Malaise 109 109
Dyspnea 104 104
Sepsis 103 103
Dizziness 96 96
Chest Pain 90 90
Neuropathy 90 90
Neck Pain 86 86
Cognitive Changes 84 84
Muscular Rigidity 84 84
Cramp(s) 82 82
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Distress 78 78
Urinary Retention 75 76
Foreign Body Reaction 69 69
Discharge 68 68
High Blood Pressure/ Hypertension 64 64
Spinal Cord Injury 62 62
Chills 57 57
Convulsion/Seizure 57 57
Loss of consciousness 56 56
Cardiac Arrest 56 56
Pneumonia 55 55
Cellulitis 55 55
Myocardial Infarction 55 55
Skin Irritation 53 53
Injury 51 51

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
2 Medtronic Neuromodulation II Jan-06-2023
3 Medtronic Neuromodulation II Aug-25-2022
4 Medtronic Neuromodulation II Aug-24-2022
5 Medtronic Neuromodulation II May-23-2022
6 Medtronic Neuromodulation II Nov-24-2021
7 Medtronic Neuromodulation II Jul-28-2021
8 Medtronic Neuromodulation II May-06-2021
9 Medtronic Neuromodulation II Jan-14-2021
10 Medtronic Neuromodulation II Jul-13-2018
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