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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 38

MDR Year MDR Reports MDR Events
2018 23626 23626
2019 30039 30039
2020 28106 28106
2021 24330 24330
2022 23271 23271
2023 20636 20636

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37445 37445
Charging Problem 17941 17941
Battery Problem 14575 14575
High impedance 14528 14528
Insufficient Information 12491 12491
Migration 11979 11979
Unexpected Therapeutic Results 8755 8755
Therapeutic or Diagnostic Output Failure 8582 8582
Wireless Communication Problem 7381 7381
Improper or Incorrect Procedure or Method 5823 5823
Overheating of Device 5818 5818
Communication or Transmission Problem 5759 5759
Failure to Deliver Energy 5557 5557
Migration or Expulsion of Device 5143 5143
Inappropriate/Inadequate Shock/Stimulation 4341 4341
Energy Output Problem 4048 4048
Failure to Interrogate 3351 3351
Fracture 3081 3081
Unintended Collision 3071 3071
Delayed Charge Time 3038 3038
Premature Elective Replacement Indicator 2990 2990
Use of Device Problem 2586 2586
Impedance Problem 2427 2427
Device Operates Differently Than Expected 2113 2113
Patient Device Interaction Problem 2047 2047
Intermittent Continuity 1838 1838
Break 1810 1810
No Device Output 1704 1704
Connection Problem 1642 1642
Premature Discharge of Battery 1640 1640
Therapy Delivered to Incorrect Body Area 1474 1474
Malposition of Device 1403 1403
Defective Device 1290 1290
Low impedance 1089 1089
Electromagnetic Compatibility Problem 1025 1025
Positioning Problem 944 944
Device Displays Incorrect Message 898 898
Display or Visual Feedback Problem 872 872
Unstable 862 862
Electromagnetic Interference 698 698
Application Program Freezes, Becomes Nonfunctional 660 660
Data Problem 626 626
Disconnection 591 591
Patient-Device Incompatibility 532 532
No Apparent Adverse Event 510 510
Low Battery 495 495
Application Program Problem 487 487
Material Integrity Problem 459 459
Device Inoperable 393 393
Failure to Charge 360 360
Material Frayed 300 300
Temperature Problem 272 272
Device Dislodged or Dislocated 240 240
Pocket Stimulation 215 215
Appropriate Term/Code Not Available 200 200
Material Deformation 190 190
Loss of Data 190 190
Failure to Power Up 190 190
Difficult to Remove 189 189
Device Difficult to Program or Calibrate 164 164
Premature End-of-Life Indicator 153 153
Operating System Becomes Nonfunctional 150 150
Material Twisted/Bent 144 144
Intermittent Energy Output 140 140
Material Fragmentation 134 134
Computer Software Problem 134 134
Difficult to Insert 123 123
Human-Device Interface Problem 111 111
Unexpected Shutdown 110 110
Material Split, Cut or Torn 105 105
Environmental Compatibility Problem 99 99
Shipping Damage or Problem 97 97
Device Or Device Fragments Location Unknown 96 96
Device Contamination with Chemical or Other Material 89 89
Detachment of Device or Device Component 81 81
Energy Output To Patient Tissue Incorrect 79 79
Degraded 69 69
Audible Prompt/Feedback Problem 66 66
Power Problem 64 64
Unintended Movement 60 60
Inadequacy of Device Shape and/or Size 55 55
Unable to Obtain Readings 52 52
Material Separation 49 49
Material Protrusion/Extrusion 48 48
Device Damaged by Another Device 46 46
Mechanical Problem 44 44
Loss of Power 43 43
Output Problem 40 40
Failure to Disconnect 37 37
Improper Device Output 35 35
Electro-Static Discharge 33 33
Vibration 31 31
Component Missing 29 29
Failure to Fire 29 29
Entrapment of Device 28 28
Noise, Audible 27 27
Failure to Advance 23 23
Ambient Noise Problem 21 21
Structural Problem 20 20
Inadequate Instructions for Non-Healthcare Professional 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 50583 50583
No Clinical Signs, Symptoms or Conditions 21801 21801
Pain 17489 17492
No Known Impact Or Consequence To Patient 13548 13550
No Code Available 12222 12222
Therapeutic Effects, Unexpected 7399 7405
Discomfort 6361 6361
Unspecified Infection 5463 5464
No Consequences Or Impact To Patient 5078 5079
Insufficient Information 4001 4001
Undesired Nerve Stimulation 3662 3662
Implant Pain 3426 3426
Burning Sensation 3289 3289
Electric Shock 3218 3218
Failure of Implant 2660 2660
Therapeutic Response, Decreased 2336 2337
Complaint, Ill-Defined 2135 2136
Post Operative Wound Infection 1988 1988
Bacterial Infection 1378 1378
Device Overstimulation of Tissue 1320 1320
Wound Dehiscence 998 998
Ambulation Difficulties 983 983
Fluid Discharge 980 980
Cerebrospinal Fluid Leakage 945 945
Numbness 935 935
Erosion 877 877
Fall 835 835
Hematoma 827 827
Headache 715 715
Swelling 650 650
Impaired Healing 635 635
Scar Tissue 541 542
Burn(s) 523 523
Fever 510 510
Paralysis 503 503
Swelling/ Edema 501 501
Muscle Weakness 497 497
Death 437 437
Erythema 428 428
Weight Changes 381 381
Purulent Discharge 379 379
No Information 377 377
Pocket Erosion 365 365
Hypersensitivity/Allergic reaction 351 351
Sleep Dysfunction 344 344
Tingling 328 328
Seroma 312 312
Muscle Spasm(s) 291 291
Nausea 290 290
Device Embedded In Tissue or Plaque 285 285
Staphylococcus Aureus 264 264
Inflammation 263 263
Irritation 238 238
Skin Inflammation/ Irritation 224 224
Cramp(s) /Muscle Spasm(s) 223 223
Paresthesia 219 219
Bruise/Contusion 219 219
Weakness 219 219
Itching Sensation 212 212
Hemorrhage/Bleeding 210 210
Abdominal Pain 206 206
Abscess 186 186
Skin Erosion 170 170
Vomiting 166 166
Stroke/CVA 161 161
Rash 160 160
Anxiety 147 147
Nerve Damage 143 143
Incontinence 140 140
Neurological Deficit/Dysfunction 138 138
Sepsis 135 135
Shaking/Tremors 123 123
Malaise 122 122
Dizziness 116 116
Headache, Lumbar Puncture 115 115
Dyspnea 115 115
Seizures 113 113
Alteration In Body Temperature 109 109
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 104 104
Chest Pain 102 102
Neck Pain 100 100
Neuropathy 98 98
Cognitive Changes 93 93
Muscular Rigidity 88 88
Distress 85 85
Cramp(s) 82 82
Urinary Retention 81 82
Myocardial Infarction 78 78
High Blood Pressure/ Hypertension 72 72
Foreign Body Reaction 71 71
Foreign Body In Patient 69 69
Discharge 68 68
Chills 67 67
Spinal Cord Injury 67 67
Convulsion/Seizure 67 67
Cardiac Arrest 66 66
Pneumonia 63 63
Fatigue 61 61
Loss of consciousness 60 60
Cellulitis 59 59

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 Jul-21-2023
4 Medtronic Neuromodulation II Jun-29-2023
5 Medtronic Neuromodulation II Jan-06-2023
6 Medtronic Neuromodulation II Aug-25-2022
7 Medtronic Neuromodulation II Aug-24-2022
8 Medtronic Neuromodulation II May-23-2022
9 Medtronic Neuromodulation II Nov-24-2021
10 Medtronic Neuromodulation II Jul-28-2021
11 Medtronic Neuromodulation II May-06-2021
12 Medtronic Neuromodulation II Jan-14-2021
13 Medtronic Neuromodulation II Jul-13-2018
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