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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
18 37 45 36 42 30

MDR Year MDR Reports MDR Events
2015 3089 3089
2016 3555 3555
2017 3576 3576
2018 4512 4512
2019 2988 2988
2020 2097 2097

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5064 5064
Device Operates Differently Than Expected 2977 2977
High impedance 2757 2757
Failure to Deliver Energy 1520 1520
Battery Problem 1424 1424
Low impedance 1189 1189
Charging Problem 1146 1146
Break 1139 1139
Device Displays Incorrect Message 1013 1013
Inappropriate/Inadequate Shock/Stimulation 997 997
Communication or Transmission Problem 943 943
Component Misassembled 827 827
Unintended Collision 761 761
Insufficient Information 750 750
Premature Discharge of Battery 663 663
Low Battery 639 639
Electromagnetic Compatibility Problem 639 639
Migration or Expulsion of Device 581 581
Malposition of Device 512 512
Energy Output Problem 458 458
Impedance Problem 403 403
Delayed Charge Time 368 368
Intermittent Continuity 368 368
Therapy Delivered to Incorrect Body Area 347 347
Failure to Interrogate 324 324
Electromagnetic Interference 291 291
Connection Problem 265 265
Material Deformation 238 238
Shipping Damage or Problem 237 237
Improper or Incorrect Procedure or Method 234 234
Therapeutic or Diagnostic Output Failure 228 228
Unstable 223 223
Display or Visual Feedback Problem 142 142
Overheating of Device 140 140
Premature Elective Replacement Indicator 140 140
No Device Output 137 137
Material Integrity Problem 134 134
Pocket Stimulation 126 126
Device Or Device Fragments Location Unknown 103 103
Patient Device Interaction Problem 99 99
Device Contamination with Chemical or Other Material 82 82
Positioning Problem 82 82
Data Problem 81 81
Bent 77 77
Appropriate Term/Code Not Available 66 66
Disconnection 64 64
Material Twisted/Bent 63 63
Loss of Data 61 61
Incorrect, Inadequate or Imprecise Resultor Readings 58 58
Unexpected Therapeutic Results 56 56
Environmental Compatibility Problem 53 53
Human-Device Interface Problem 47 47
Fracture 47 47
Use of Device Problem 46 46
Activation, Positioning or SeparationProblem 43 43
Energy Output To Patient Tissue Incorrect 41 41
Failure to Power Up 35 35
Wireless Communication Problem 35 35
Device Difficult to Program or Calibrate 35 35
Migration 34 34
Improper Device Output 33 33
Inadequacy of Device Shape and/or Size 30 30
Shelf Life Exceeded 28 28
Unable to Obtain Readings 26 26
Difficult to Insert 25 25
Difficult to Remove 25 25
Device Damaged by Another Device 23 23
Difficult to Open or Close 23 23
Component Missing 21 21
Peeled/Delaminated 19 19
Electro-Static Discharge 19 19
Vibration 18 18
Patient-Device Incompatibility 14 14
Defective Device 13 13
Ambient Noise Problem 13 13
Patient Lead 13 13
Device Markings/Labelling Problem 12 12
Material Frayed 12 12
Use of Incorrect Control Settings 12 12
Loss of Power 11 11
Device Inoperable 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Noise, Audible 10 10
Labelling, Instructions for Use or Training Problem 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Failure to Advance 8 8
Electrical /Electronic Property Problem 7 7
Degraded 7 7
Stretched 7 7
Temperature Problem 6 6
Electrical Shorting 6 6
Unintended Movement 6 6
Incorrect Device Or Component Shipped 5 5
Device Contaminated During Manufacture or Shipping 5 5
Contamination 5 5
Inadequate Instructions for Non-Healthcare Professional 5 5
No Display/Image 5 5
Mechanical Problem 5 5
Nonstandard Device 4 4
Material Fragmentation 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6859 6859
Complaint, Ill-Defined 2350 2350
Therapeutic Effects, Unexpected 2169 2169
Therapeutic Response, Decreased 1965 1965
Shaking/Tremors 1838 1839
Unspecified Infection 1778 1779
Ambulation Difficulties 1070 1070
Electric Shock 978 978
No Consequences Or Impact To Patient 962 962
Pain 711 711
Dysphasia 660 660
Cognitive Changes 642 643
Muscular Rigidity 469 470
Fall 466 466
Tingling 424 424
Inadequate Pain Relief 419 419
Undesired Nerve Stimulation 397 397
Discomfort 392 392
Neurological Deficit/Dysfunction 383 384
Erosion 343 343
Seizures 335 335
Stroke/CVA 317 317
Dyskinesia 316 316
No Code Available 288 289
Post Operative Wound Infection 254 254
Erythema 232 232
Staphylococcus Aureus 230 230
Swelling 227 227
Intracranial Hemorrhage 216 216
Headache 211 211
Skin Erosion 197 197
Burning Sensation 194 194
Bacterial Infection 174 174
Pocket Erosion 172 172
Wound Dehiscence 171 171
Anxiety 170 170
Purulent Discharge 166 166
Confusion/ Disorientation 158 158
Device Overstimulation of Tissue 158 158
Hematoma 152 152
Dizziness 151 151
Death 147 147
Sleep Dysfunction 146 146
Muscle Spasm(s) 144 144
Weakness 136 136
Edema 130 130
Fatigue 129 129
Fluid Discharge 129 129
Malaise 123 123
Numbness 122 122
Scar Tissue 120 120
Dysphagia/ Odynophagia 119 119
Depression 116 116
Injury 113 113
Emotional Changes 106 106
Loss of consciousness 106 106
Muscle Weakness 105 105
Hemorrhage, Cerebral 100 100
Test Result 99 100
Impaired Healing 98 98
Memory Loss/Impairment 93 93
Hemorrhage/Bleeding 86 86
Neck Stiffness 83 83
Inflammation 79 79
Irritability 79 79
Foreign Body Reaction 77 77
Dementia 76 76
Twitching 71 71
Bone Fracture(s) 70 70
Paresis 70 70
Seroma 65 65
Irritation 64 64
Fever 64 64
Weight Changes 63 63
Visual Impairment 58 58
Neck Pain 58 58
Abscess 51 51
Transient Ischemic Attack 48 48
Cramp(s) 48 48
Nausea 48 48
Alteration In Body Temperature 48 48
Adhesion(s) 47 47
Distress 47 47
Visual Disturbances 47 47
Lethargy 47 47
Hemorrhage, Subdural 46 46
Incontinence 43 43
Bruise/Contusion 42 42
Tissue Breakdown 41 41
Dyspnea 40 40
Twiddlers Syndrome 39 39
Hypersensitivity/Allergic reaction 37 37
High Blood Pressure/ Hypertension 37 37
Pulmonary Embolism 35 35
Pneumonia 35 35
Paralysis 35 35
Infarction, Cerebral 34 34
Tissue Damage 33 33
Device Embedded In Tissue or Plaque 33 33
Chest Pain 32 32

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Aug-23-2017
2 Medtronic Neuromodulation II Dec-03-2016
3 Medtronic Neuromodulation II Aug-24-2016
4 Medtronic Neuromodulation II Aug-19-2016
5 Medtronic Neuromodulation II May-15-2015
6 St. Jude Medical, Inc. II Dec-10-2018
7 St. Jude Medical, Inc. II Oct-17-2017
8 St. Jude Medical, Inc. II Jul-07-2017
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