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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)
2017 2018 2019 2020 2021 2022
94 64 69 52 56 36

MDR Year MDR Reports MDR Events
2017 18606 18606
2018 23625 23625
2019 30039 30039
2020 28105 28105
2021 24336 24336
2022 12856 12856

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36186 36186
Charging Problem 15931 15931
High impedance 12644 12644
Battery Problem 11858 11858
Insufficient Information 9897 9897
Migration 9079 9079
Therapeutic or Diagnostic Output Failure 7492 7492
Unexpected Therapeutic Results 6766 6766
Failure to Deliver Energy 6336 6336
Device Operates Differently Than Expected 5734 5734
Improper or Incorrect Procedure or Method 5679 5679
Migration or Expulsion of Device 5439 5439
Communication or Transmission Problem 5396 5396
Wireless Communication Problem 5298 5298
Inappropriate/Inadequate Shock/Stimulation 4113 4113
Premature Elective Replacement Indicator 3633 3633
Energy Output Problem 3577 3577
Use of Device Problem 3554 3554
Unintended Collision 3479 3479
Failure to Interrogate 2900 2900
Delayed Charge Time 2625 2625
Fracture 2486 2486
Impedance Problem 2227 2227
Device Displays Incorrect Message 2216 2216
No Device Output 2189 2189
Overheating of Device 2101 2101
Intermittent Continuity 2061 2061
Break 1799 1799
Patient Device Interaction Problem 1782 1782
Therapy Delivered to Incorrect Body Area 1723 1723
Malposition of Device 1615 1615
Premature Discharge of Battery 1575 1575
Low Battery 1341 1341
Device Inoperable 1326 1326
Connection Problem 1156 1156
Electromagnetic Compatibility Problem 1136 1136
Low impedance 1064 1064
Defective Device 1006 1006
Positioning Problem 993 993
Unstable 954 954
Electromagnetic Interference 763 763
Material Integrity Problem 675 675
Application Program Freezes, Becomes Nonfunctional 660 660
Disconnection 591 591
Failure to Charge 579 579
Display or Visual Feedback Problem 548 548
No Apparent Adverse Event 524 524
Patient-Device Incompatibility 503 503
Data Problem 489 489
Temperature Problem 272 272
Pocket Stimulation 235 235
Application Program Problem 233 233
Material Deformation 223 223
Energy Output To Patient Tissue Incorrect 215 215
Device Or Device Fragments Location Unknown 209 209
Device Dislodged or Dislocated 203 203
Failure to Power Up 194 194
Loss of Data 190 190
Appropriate Term/Code Not Available 184 184
Device Difficult to Program or Calibrate 180 180
Difficult to Remove 170 170
Premature End-of-Life Indicator 169 169
Shipping Damage or Problem 137 137
Improper Device Output 128 128
Difficult to Insert 125 125
Material Twisted/Bent 121 121
Human-Device Interface Problem 117 117
Environmental Compatibility Problem 116 116
Intermittent Energy Output 112 112
Nonstandard Device 107 107
Material Fragmentation 101 101
Unexpected Shutdown 94 94
Device Contamination with Chemical or Other Material 91 91
Material Split, Cut or Torn 86 86
Material Frayed 85 85
Detachment of Device or Device Component 81 81
Material Separation 75 75
Unable to Obtain Readings 70 70
Inadequacy of Device Shape and/or Size 69 69
Telemetry Discrepancy 62 62
Material Protrusion/Extrusion 59 59
Device Stops Intermittently 57 57
Power Problem 56 56
Degraded 54 54
Unintended Movement 53 53
Component Missing 52 52
Bent 44 44
Device Damaged by Another Device 44 44
Loss of Power 41 41
Mechanical Problem 39 39
Inadequate Instructions for Non-Healthcare Professional 38 38
Kinked 37 37
Vibration 36 36
Electro-Static Discharge 36 36
Noise, Audible 36 36
Failure to Disconnect 29 29
Failure to Fire 29 29
Operating System Becomes Nonfunctional 28 28
Computer Software Problem 27 27
Ambient Noise Problem 25 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 42714 42714
No Known Impact Or Consequence To Patient 18947 18949
Pain 18291 18294
No Code Available 12284 12284
No Clinical Signs, Symptoms or Conditions 11318 11318
Therapeutic Effects, Unexpected 10574 10580
Discomfort 7018 7018
Unspecified Infection 5282 5284
No Consequences Or Impact To Patient 5080 5081
Undesired Nerve Stimulation 3548 3548
Therapeutic Response, Decreased 3427 3428
Electric Shock 3255 3255
Complaint, Ill-Defined 3139 3140
Burning Sensation 2681 2681
Insufficient Information 2323 2323
Post Operative Wound Infection 1906 1906
Implant Pain 1732 1732
Device Overstimulation of Tissue 1624 1624
Bacterial Infection 1457 1457
Failure of Implant 1453 1453
Ambulation Difficulties 1127 1127
Swelling 961 961
Wound Dehiscence 946 946
Numbness 929 929
No Information 924 924
Fall 922 922
Erosion 877 877
Fluid Discharge 875 875
Cerebrospinal Fluid Leakage 852 852
Hematoma 801 801
Headache 687 687
Impaired Healing 600 600
Scar Tissue 583 584
Fever 541 541
Weight Changes 536 536
Paralysis 522 522
Death 509 509
Burn(s) 467 467
Tingling 457 457
Erythema 437 437
Muscle Weakness 421 421
Muscle Spasm(s) 419 419
Sleep Dysfunction 418 418
Purulent Discharge 369 369
Staphylococcus Aureus 351 351
Seroma 342 342
Irritation 337 337
Hypersensitivity/Allergic reaction 314 314
Pocket Erosion 310 310
Nausea 294 294
Weakness 285 285
Device Embedded In Tissue or Plaque 279 279
Swelling/ Edema 278 278
Inflammation 271 271
Bruise/Contusion 247 247
Itching Sensation 201 201
Abdominal Pain 199 199
Skin Erosion 197 197
Abscess 191 191
Hemorrhage/Bleeding 184 184
Anxiety 173 173
Nerve Damage 169 169
Neurological Deficit/Dysfunction 163 163
Rash 162 162
Alteration In Body Temperature 161 161
Seizures 157 157
Malaise 157 157
Incontinence 154 154
Vomiting 153 153
Discharge 150 150
Cramp(s) /Muscle Spasm(s) 148 148
Stroke/CVA 146 146
Shaking/Tremors 144 144
Skin Inflammation/ Irritation 135 135
Neuropathy 129 129
Dyspnea 123 123
Headache, Lumbar Puncture 123 123
Cramp(s) 118 118
Cognitive Changes 118 118
Paresthesia 117 117
Distress 116 116
Dizziness 111 111
Muscular Rigidity 111 111
Neck Pain 109 109
Sepsis 107 107
Chest Pain 104 104
Foreign Body Reaction 92 92
Urinary Retention 84 85
High Blood Pressure/ Hypertension 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Injury 77 77
Edema 75 75
Twitching 72 72
Loss of consciousness 71 71
Spinal Cord Injury 71 71
Skin Irritation 69 69
Reaction 68 68
Cellulitis 68 68
Chills 67 67
Patient Problem/Medical Problem 67 67

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
2 Medtronic Neuromodulation II May-23-2022
3 Medtronic Neuromodulation II Nov-24-2021
4 Medtronic Neuromodulation II Jul-28-2021
5 Medtronic Neuromodulation II May-06-2021
6 Medtronic Neuromodulation II Jan-14-2021
7 Medtronic Neuromodulation II Jul-13-2018
8 St. Jude Medical, Inc. II Oct-17-2017
9 St. Jude Medical, Inc. II Jul-07-2017
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