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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 38

MDR Year MDR Reports MDR Events
2019 30039 30039
2020 28106 28106
2021 24332 24332
2022 23272 23272
2023 33526 33526
2024 16526 16527

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35765 35765
Charging Problem 19570 19570
High impedance 16341 16341
Battery Problem 16030 16030
Insufficient Information 13936 13936
Migration 13925 13926
Unexpected Therapeutic Results 9833 9833
Therapeutic or Diagnostic Output Failure 9492 9492
Wireless Communication Problem 8837 8837
Overheating of Device 8313 8313
Communication or Transmission Problem 5807 5807
Improper or Incorrect Procedure or Method 5558 5558
Failure to Deliver Energy 4818 4818
Migration or Expulsion of Device 4593 4593
Inappropriate/Inadequate Shock/Stimulation 4256 4256
Connection Problem 3927 3927
Energy Output Problem 3806 3806
Failure to Interrogate 3595 3595
Fracture 3377 3377
Delayed Charge Time 3346 3346
Unintended Collision 2491 2491
Failure to Power Up 2413 2413
Impedance Problem 2359 2359
Material Integrity Problem 2151 2151
Display or Visual Feedback Problem 2076 2076
Patient Device Interaction Problem 1865 1865
Break 1653 1653
Premature Discharge of Battery 1610 1610
Premature Elective Replacement Indicator 1584 1584
Intermittent Continuity 1580 1580
Defective Device 1491 1491
Use of Device Problem 1461 1461
Therapy Delivered to Incorrect Body Area 1220 1220
Malposition of Device 1189 1189
No Device Output 1122 1122
Low impedance 1012 1012
Operating System Becomes Nonfunctional 918 918
Positioning Problem 867 867
Electromagnetic Compatibility Problem 845 845
Data Problem 746 746
Unstable 735 735
Application Program Problem 689 689
Electromagnetic Interference 562 562
Disconnection 538 538
No Apparent Adverse Event 520 520
Patient-Device Incompatibility 505 505
Material Frayed 430 430
Application Program Freezes, Becomes Nonfunctional 383 383
Temperature Problem 292 292
Computer Software Problem 291 291
Device Dislodged or Dislocated 218 218
Pocket Stimulation 203 203
Material Deformation 176 176
Material Twisted/Bent 164 164
Loss of Data 162 162
Audible Prompt/Feedback Problem 158 158
Intermittent Energy Output 156 156
Device Difficult to Program or Calibrate 156 156
Difficult to Remove 155 155
Material Fragmentation 150 150
Failure to Charge 140 140
Unexpected Shutdown 110 110
Power Problem 105 105
Human-Device Interface Problem 104 104
Difficult to Insert 101 101
Mechanical Problem 97 97
Premature End-of-Life Indicator 92 92
Material Split, Cut or Torn 88 88
Device Contamination with Chemical or Other Material 78 78
Environmental Compatibility Problem 76 76
Appropriate Term/Code Not Available 76 76
Detachment of Device or Device Component 71 71
Shipping Damage or Problem 66 66
Degraded 66 66
Vibration 51 51
Device Damaged by Another Device 47 47
Device Displays Incorrect Message 46 46
Noise, Audible 38 38
Failure to Disconnect 36 36
Unable to Obtain Readings 34 34
Inadequacy of Device Shape and/or Size 33 33
No Display/Image 28 28
Entrapment of Device 25 25
Structural Problem 25 25
Material Protrusion/Extrusion 25 25
Output Problem 23 23
Failure to Advance 22 22
Corroded 22 22
Material Separation 21 21
Electro-Static Discharge 20 20
Separation Failure 19 19
Inappropriate or Unexpected Reset 19 19
Component Missing 17 17
Unauthorized Access to Computer System 17 17
Ambient Noise Problem 15 15
Unintended Power Up 15 15
Use of Incorrect Control/Treatment Settings 13 13
Incomplete or Inadequate Connection 13 13
Unintended Movement 12 12
Unintended Electrical Shock 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 53128 53129
No Clinical Signs, Symptoms or Conditions 35160 35160
Pain 16338 16338
No Code Available 10738 10738
No Known Impact Or Consequence To Patient 7180 7180
Failure of Implant 5967 5967
Discomfort 5480 5480
Insufficient Information 5284 5284
Unspecified Infection 5265 5265
Implant Pain 4957 4957
No Consequences Or Impact To Patient 4222 4223
Therapeutic Effects, Unexpected 3890 3890
Undesired Nerve Stimulation 3666 3666
Burning Sensation 3614 3614
Electric Shock 2991 2991
Post Operative Wound Infection 1886 1886
Bacterial Infection 1368 1368
Therapeutic Response, Decreased 1234 1234
Complaint, Ill-Defined 1134 1134
Device Overstimulation of Tissue 1005 1005
Wound Dehiscence 992 992
Fluid Discharge 963 963
Cerebrospinal Fluid Leakage 922 922
Numbness 875 875
Erosion 847 847
Ambulation Difficulties 822 822
Hematoma 784 784
Headache 688 688
Swelling/ Edema 677 677
Impaired Healing 622 622
Fall 589 589
Muscle Weakness 566 566
Burn(s) 530 530
Scar Tissue 490 490
Paralysis 478 478
Fever 437 437
Erythema 403 403
Pocket Erosion 385 385
Purulent Discharge 379 379
Swelling 370 370
Hypersensitivity/Allergic reaction 345 345
Death 326 326
Sleep Dysfunction 301 301
Cramp(s) /Muscle Spasm(s) 298 298
Paresthesia 292 292
Skin Inflammation/ Irritation 280 280
Seroma 266 266
Device Embedded In Tissue or Plaque 262 262
Nausea 252 252
Inflammation 229 229
Hemorrhage/Bleeding 222 222
Abdominal Pain 197 197
Itching Sensation 194 194
Weight Changes 189 189
Bruise/Contusion 187 187
Tingling 180 180
Muscle Spasm(s) 176 176
Skin Erosion 164 164
Staphylococcus Aureus 161 161
Abscess 159 159
Stroke/CVA 157 157
Vomiting 157 157
Sepsis 153 153
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 146 146
Irritation 143 143
Weakness 142 142
Rash 140 140
Nerve Damage 122 122
Incontinence 117 117
Anxiety 116 116
Shaking/Tremors 111 111
Foreign Body In Patient 110 110
Dizziness 109 109
Chest Pain 102 102
Headache, Lumbar Puncture 98 98
Neck Pain 96 96
Dyspnea 96 96
Neurological Deficit/Dysfunction 95 95
Convulsion/Seizure 90 90
No Information 83 83
Malaise 81 81
Myocardial Infarction 79 79
Neuropathy 76 76
Cancer 76 76
Cognitive Changes 76 76
Cardiac Arrest 74 74
Movement Disorder 72 72
Spinal Cord Injury 67 67
Seizures 67 67
Urinary Retention 63 63
High Blood Pressure/ Hypertension 63 63
Alteration In Body Temperature 61 61
Thrombosis/Thrombus 60 60
Pneumonia 60 60
Muscular Rigidity 58 58
Foreign Body Reaction 57 57
Alteration in Body Temperature 56 56
Distress 55 55
Loss of consciousness 54 54
Chills 54 54

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