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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)
2015 2016 2017 2018 2019 2020
72 92 94 64 69 42

MDR Year MDR Reports MDR Events
2015 11675 11675
2016 15634 15634
2017 18600 18600
2018 23621 23621
2019 30045 30045
2020 20638 20638

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32180 32180
Charging Problem 14987 14987
Device Operates Differently Than Expected 12517 12517
High impedance 9881 9881
Battery Problem 8551 8551
Failure to Deliver Energy 8244 8244
Communication or Transmission Problem 6787 6787
Insufficient Information 6749 6749
Migration or Expulsion of Device 6369 6369
Improper or Incorrect Procedure or Method 4541 4541
Device Displays Incorrect Message 4472 4472
Therapeutic or Diagnostic Output Failure 4243 4243
Inappropriate/Inadequate Shock/Stimulation 4241 4241
Use of Device Problem 4082 4082
Unintended Collision 3998 3998
Migration 3964 3964
Unexpected Therapeutic Results 3834 3834
Premature Elective Replacement Indicator 3417 3417
Failure to Interrogate 3370 3370
Low Battery 2726 2726
Energy Output Problem 2585 2585
Intermittent Continuity 2553 2553
No Device Output 2510 2510
Therapy Delivered to Incorrect Body Area 2426 2426
Delayed Charge Time 2382 2382
Wireless Communication Problem 2204 2204
Overheating of Device 2130 2130
Malposition of Device 2118 2118
Break 2099 2099
No Apparent Adverse Event 1814 1814
Device Inoperable 1795 1795
Impedance Problem 1664 1664
Fracture 1583 1583
Electromagnetic Compatibility Problem 1463 1463
Connection Problem 1463 1463
Positioning Problem 1389 1389
Premature Discharge of Battery 1367 1367
Failure to Charge 1336 1336
Patient Device Interaction Problem 1297 1297
Unstable 1124 1124
Material Integrity Problem 1033 1033
Electromagnetic Interference 989 989
Low impedance 960 960
Application Program Freezes, Becomes Nonfunctional 657 657
Disconnection 587 587
Energy Output To Patient Tissue Incorrect 559 559
Display or Visual Feedback Problem 535 535
Defective Device 495 495
Device Or Device Fragments Location Unknown 451 451
Nonstandard Device 445 445
Pocket Stimulation 333 333
Patient-Device Incompatibility 319 319
Data Problem 295 295
Improper Device Output 288 288
Material Deformation 244 244
Device Difficult to Program or Calibrate 236 236
Failure to Power Up 218 218
Temperature Problem 217 217
Device Dislodged or Dislocated 198 198
Appropriate Term/Code Not Available 193 193
Loss of Data 193 193
Telemetry Discrepancy 180 180
Premature End-of-Life Indicator 172 172
Difficult to Remove 168 168
Human-Device Interface Problem 146 146
Shipping Damage or Problem 145 145
Bent 144 144
Kinked 143 143
Environmental Compatibility Problem 141 141
Difficult to Insert 132 132
Unable to Obtain Readings 124 124
Device Contamination with Chemical or Other Material 116 116
Device Stops Intermittently 97 97
Inadequacy of Device Shape and/or Size 95 95
Detachment of Device or Device Component 93 93
Material Frayed 92 92
Patient Lead 84 84
Material Separation 82 82
Inadequate Instructions for Non-Healthcare Professional 79 79
Unexpected Shutdown 71 71
Material Protrusion/Extrusion 69 69
Material Split, Cut or Torn 69 69
Component Missing 69 69
Material Twisted/Bent 57 57
Unintended Movement 56 56
Electro-Static Discharge 55 55
Material Fragmentation 55 55
Intermittent Energy Output 54 54
Degraded 48 48
Shelf Life Exceeded 43 43
Loss of Power 43 43
Vibration 42 42
Power Problem 40 40
Noise, Audible 38 38
Battery 36 36
Mechanical Problem 34 34
Device Damaged by Another Device 32 32
Ambient Noise Problem 32 32
Failure to Fire 29 29
Defective Component 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 26163 26163
No Known Impact Or Consequence To Patient 24478 24479
Pain 21569 21570
Therapeutic Effects, Unexpected 16882 16882
No Code Available 10754 10754
Discomfort 7963 7963
Therapeutic Response, Decreased 5494 5494
Complaint, Ill-Defined 4900 4900
No Consequences Or Impact To Patient 4868 4869
Unspecified Infection 4860 4861
Electric Shock 3801 3801
Undesired Nerve Stimulation 3665 3665
Burning Sensation 3022 3022
Device Overstimulation of Tissue 2233 2233
Bacterial Infection 1725 1725
Post Operative Wound Infection 1594 1594
No Information 1584 1584
Ambulation Difficulties 1455 1455
Swelling 1396 1396
Fall 1016 1016
Numbness 949 949
Wound Dehiscence 825 825
Fluid Discharge 795 795
Erosion 766 766
Headache 737 737
Hematoma 714 714
Tingling 691 691
Scar Tissue 671 671
Cerebrospinal Fluid Leakage 666 666
Fever 640 640
Muscle Spasm(s) 640 640
Weight Changes 635 635
Impaired Healing 619 619
Erythema 582 582
Staphylococcus Aureus 557 557
Death 533 533
Irritation 512 512
Sleep Dysfunction 502 502
Paralysis 489 489
Purulent Discharge 471 471
Discharge 420 420
Failure of Implant 416 416
Weakness 377 377
Seroma 368 368
Inflammation 343 343
Nausea 335 335
Hypersensitivity/Allergic reaction 315 315
Burn(s) 308 308
Muscle Weakness 307 307
Pocket Erosion 305 305
Bruise/Contusion 296 296
Device Embedded In Tissue or Plaque 277 277
Skin Erosion 261 261
Alteration In Body Temperature 249 249
Seizures 243 243
Malaise 227 227
Itching Sensation 225 225
Abscess 220 220
Abdominal Pain 211 211
Neurological Deficit/Dysfunction 197 197
Nerve Damage 194 194
Shaking/Tremors 194 194
Distress 191 191
Neck Pain 189 189
Anxiety 188 188
Rash 187 187
Cramp(s) 182 182
Hemorrhage/Bleeding 178 178
Neuropathy 177 177
Incontinence 170 170
Vomiting 166 166
Cognitive Changes 165 165
Muscular Rigidity 157 157
Headache, Lumbar Puncture 144 144
Injury 135 135
Stroke/CVA 126 126
Dyspnea 121 121
Foreign Body Reaction 121 121
Dizziness 118 118
Twitching 111 111
Sepsis 111 111
Chest Pain 108 108
Skin Irritation 102 102
Urinary Retention 100 101
Irritability 96 96
Edema 93 93
Cellulitis 92 92
Respiratory Distress 92 92
Loss of consciousness 92 92
Test Result 90 90
High Blood Pressure/ Hypertension 89 89
Skin Inflammation 85 85
Chills 84 84
Reaction 84 84
Loss of Range of Motion 81 81
Scarring 81 81
Skin Discoloration 80 80
Spinal Cord Injury 80 80
Depression 79 79
Thrombosis 78 78

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
2 Medtronic Neuromodulation II Jul-13-2018
3 Medtronic Neuromodulation II Jun-07-2016
4 Medtronic Neuromodulation II Feb-23-2016
5 Medtronic Neuromodulation II Jun-26-2015
6 Nuvectra II Dec-17-2016
7 Nuvectra II May-03-2016
8 QiG Group LLC II Mar-18-2016
9 St. Jude Medical, Inc. II Oct-17-2017
10 St. Jude Medical, Inc. II Jul-07-2017
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