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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)
2019 2020 2021 2022 2023 2024
69 52 56 60 63 45

MDR Year MDR Reports MDR Events
2019 30039 30039
2020 28106 28106
2021 24332 24332
2022 23272 23272
2023 33527 33527
2024 19169 19170

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36330 36330
Charging Problem 19923 19923
High impedance 16641 16641
Battery Problem 16391 16391
Migration 14241 14242
Insufficient Information 14159 14159
Unexpected Therapeutic Results 9989 9989
Therapeutic or Diagnostic Output Failure 9632 9632
Wireless Communication Problem 8992 8992
Overheating of Device 8445 8445
Communication or Transmission Problem 5896 5896
Improper or Incorrect Procedure or Method 5606 5606
Failure to Deliver Energy 4926 4926
Migration or Expulsion of Device 4680 4680
Inappropriate/Inadequate Shock/Stimulation 4341 4341
Connection Problem 3981 3981
Energy Output Problem 3904 3904
Failure to Interrogate 3656 3656
Fracture 3419 3419
Delayed Charge Time 3404 3404
Unintended Collision 2530 2530
Failure to Power Up 2512 2512
Impedance Problem 2385 2385
Material Integrity Problem 2166 2166
Display or Visual Feedback Problem 2137 2137
Patient Device Interaction Problem 1889 1889
Break 1687 1687
Premature Discharge of Battery 1621 1621
Intermittent Continuity 1611 1611
Premature Elective Replacement Indicator 1584 1584
Defective Device 1517 1517
Use of Device Problem 1476 1476
Therapy Delivered to Incorrect Body Area 1240 1240
Malposition of Device 1210 1210
No Device Output 1132 1132
Low impedance 1025 1025
Operating System Becomes Nonfunctional 958 958
Positioning Problem 882 882
Electromagnetic Compatibility Problem 865 865
Data Problem 773 773
Unstable 745 745
Application Program Problem 690 690
Electromagnetic Interference 574 574
Disconnection 545 545
No Apparent Adverse Event 530 530
Patient-Device Incompatibility 508 508
Material Frayed 437 437
Application Program Freezes, Becomes Nonfunctional 383 383
Temperature Problem 299 299
Computer Software Problem 297 297
Device Dislodged or Dislocated 220 220
Pocket Stimulation 208 208
Material Deformation 185 185
Material Twisted/Bent 166 166
Loss of Data 164 164
Intermittent Energy Output 159 159
Audible Prompt/Feedback Problem 159 159
Device Difficult to Program or Calibrate 158 158
Difficult to Remove 158 158
Material Fragmentation 152 152
Failure to Charge 141 141
Unexpected Shutdown 117 117
Power Problem 108 108
Human-Device Interface Problem 104 104
Difficult to Insert 103 103
Mechanical Problem 99 99
Premature End-of-Life Indicator 92 92
Material Split, Cut or Torn 88 88
Device Contamination with Chemical or Other Material 79 79
Environmental Compatibility Problem 77 77
Appropriate Term/Code Not Available 77 77
Detachment of Device or Device Component 72 72
Degraded 67 67
Shipping Damage or Problem 66 66
Vibration 52 52
Device Damaged by Another Device 48 48
Device Displays Incorrect Message 47 47
Noise, Audible 39 39
Failure to Disconnect 36 36
Inadequacy of Device Shape and/or Size 34 34
Unable to Obtain Readings 34 34
No Display/Image 29 29
Entrapment of Device 26 26
Structural Problem 26 26
Material Protrusion/Extrusion 25 25
Output Problem 23 23
Failure to Advance 22 22
Corroded 22 22
Material Separation 21 21
Separation Failure 20 20
Electro-Static Discharge 20 20
Inappropriate or Unexpected Reset 19 19
Unauthorized Access to Computer System 19 19
Component Missing 17 17
Unintended Power Up 17 17
Ambient Noise Problem 15 15
Use of Incorrect Control/Treatment Settings 13 13
Incomplete or Inadequate Connection 13 13
Unintended Electrical Shock 12 12
Unintended Movement 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 53918 53919
No Clinical Signs, Symptoms or Conditions 35959 35959
Pain 16698 16698
No Code Available 10738 10738
No Known Impact Or Consequence To Patient 7180 7180
Failure of Implant 6383 6383
Discomfort 5540 5540
Insufficient Information 5466 5466
Unspecified Infection 5358 5358
Implant Pain 5119 5119
No Consequences Or Impact To Patient 4222 4223
Therapeutic Effects, Unexpected 3890 3890
Undesired Nerve Stimulation 3736 3736
Burning Sensation 3686 3686
Electric Shock 3052 3052
Post Operative Wound Infection 1916 1916
Bacterial Infection 1397 1397
Therapeutic Response, Decreased 1234 1234
Complaint, Ill-Defined 1134 1134
Device Overstimulation of Tissue 1026 1026
Wound Dehiscence 1016 1016
Fluid Discharge 979 979
Cerebrospinal Fluid Leakage 941 941
Numbness 892 892
Erosion 860 860
Ambulation Difficulties 841 841
Hematoma 799 799
Headache 702 702
Swelling/ Edema 699 699
Impaired Healing 639 639
Fall 597 597
Muscle Weakness 575 575
Burn(s) 537 537
Scar Tissue 502 502
Paralysis 485 485
Fever 446 446
Erythema 417 417
Pocket Erosion 389 389
Purulent Discharge 386 386
Swelling 370 370
Hypersensitivity/Allergic reaction 350 350
Death 326 326
Sleep Dysfunction 307 307
Paresthesia 306 306
Cramp(s) /Muscle Spasm(s) 302 302
Skin Inflammation/ Irritation 286 286
Device Embedded In Tissue or Plaque 269 269
Seroma 268 268
Nausea 259 259
Inflammation 234 234
Hemorrhage/Bleeding 225 225
Abdominal Pain 199 199
Itching Sensation 197 197
Bruise/Contusion 190 190
Weight Changes 189 189
Tingling 180 180
Muscle Spasm(s) 176 176
Skin Erosion 166 166
Vomiting 163 163
Stroke/CVA 162 162
Abscess 161 161
Staphylococcus Aureus 161 161
Sepsis 155 155
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 147 147
Irritation 143 143
Weakness 142 142
Rash 140 140
Nerve Damage 123 123
Anxiety 123 123
Incontinence 118 118
Shaking/Tremors 115 115
Foreign Body In Patient 114 114
Dizziness 109 109
Chest Pain 102 102
Dyspnea 99 99
Headache, Lumbar Puncture 98 98
Neck Pain 96 96
Neurological Deficit/Dysfunction 95 95
Convulsion/Seizure 91 91
No Information 83 83
Malaise 83 83
Myocardial Infarction 82 82
Movement Disorder 80 80
Cancer 78 78
Cognitive Changes 77 77
Neuropathy 77 77
Cardiac Arrest 74 74
Spinal Cord Injury 69 69
Seizures 67 67
High Blood Pressure/ Hypertension 64 64
Thrombosis/Thrombus 64 64
Urinary Retention 63 63
Pneumonia 61 61
Alteration In Body Temperature 61 61
Alteration in Body Temperature 58 58
Muscular Rigidity 58 58
Distress 58 58
Foreign Body Reaction 57 57
Loss of consciousness 55 55
Chills 54 54

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-16-2024
2 Abbott Medical I Sep-11-2023
3 Boston Scientific Neuromodulation Corporation II May-26-2020
4 Medtronic Neuromodulation II Apr-26-2024
5 Medtronic Neuromodulation II Jan-22-2024
6 Medtronic Neuromodulation II Nov-20-2023
7 Medtronic Neuromodulation II Sep-29-2023
8 Medtronic Neuromodulation II Jul-21-2023
9 Medtronic Neuromodulation II Jun-29-2023
10 Medtronic Neuromodulation II Jan-06-2023
11 Medtronic Neuromodulation II Aug-25-2022
12 Medtronic Neuromodulation II Aug-24-2022
13 Medtronic Neuromodulation II May-23-2022
14 Medtronic Neuromodulation II Nov-24-2021
15 Medtronic Neuromodulation II Jul-28-2021
16 Medtronic Neuromodulation II May-06-2021
17 Medtronic Neuromodulation II Jan-14-2021
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