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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)
2017 2018 2019 2020 2021 2022
45 36 42 37 36 14

MDR Year MDR Reports MDR Events
2017 3560 3560
2018 4494 4494
2019 2818 2818
2020 2674 2674
2021 2431 2431
2022 780 780

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4195 4195
High impedance 2469 2469
Battery Problem 1571 1571
Failure to Deliver Energy 1281 1281
Device Operates Differently Than Expected 1264 1264
Charging Problem 1147 1147
Insufficient Information 1102 1102
Low impedance 1035 1035
Communication or Transmission Problem 900 900
Break 861 861
Component Misassembled 827 827
Inappropriate/Inadequate Shock/Stimulation 773 773
Unintended Collision 562 562
Energy Output Problem 532 532
Premature Discharge of Battery 471 471
Device Displays Incorrect Message 456 456
Electromagnetic Compatibility Problem 453 453
Migration or Expulsion of Device 430 430
Malposition of Device 409 409
Delayed Charge Time 380 380
Impedance Problem 361 361
Therapeutic or Diagnostic Output Failure 323 323
Low Battery 318 318
Failure to Interrogate 308 308
Improper or Incorrect Procedure or Method 278 278
Therapy Delivered to Incorrect Body Area 268 268
Connection Problem 246 246
Electromagnetic Interference 233 233
Unstable 219 219
Material Deformation 213 213
Intermittent Continuity 205 205
Shipping Damage or Problem 189 189
Patient Device Interaction Problem 147 147
Premature Elective Replacement Indicator 142 142
Display or Visual Feedback Problem 141 141
Material Integrity Problem 117 117
Data Problem 112 112
Material Twisted/Bent 107 107
No Device Output 102 102
Fracture 101 101
Overheating of Device 96 96
Pocket Stimulation 87 87
Loss of Data 83 83
Migration 81 81
Wireless Communication Problem 74 74
Unexpected Therapeutic Results 73 73
Positioning Problem 71 71
Use of Device Problem 67 67
Appropriate Term/Code Not Available 63 63
Device Contamination with Chemical or Other Material 62 62
Difficult to Open or Close 54 54
Disconnection 48 48
Incorrect, Inadequate or Imprecise Resultor Readings 46 46
Activation, Positioning or SeparationProblem 45 45
Bent 43 43
Device Or Device Fragments Location Unknown 40 40
Failure to Power Up 37 37
Human-Device Interface Problem 30 30
Environmental Compatibility Problem 27 27
Device Difficult to Program or Calibrate 27 27
No Apparent Adverse Event 24 24
Difficult to Insert 23 23
Energy Output To Patient Tissue Incorrect 23 23
Difficult to Remove 20 20
Component Missing 20 20
Defective Device 19 19
Inadequacy of Device Shape and/or Size 17 17
Unable to Obtain Readings 16 16
Application Program Problem 16 16
Device Damaged by Another Device 14 14
Improper Device Output 14 14
Peeled/Delaminated 14 14
Electro-Static Discharge 13 13
Patient-Device Incompatibility 13 13
Failure to Advance 12 12
Noise, Audible 12 12
Vibration 12 12
Shelf Life Exceeded 11 11
Material Frayed 11 11
Device Markings/Labelling Problem 11 11
Degraded 10 10
Loss of Power 9 9
Device Inoperable 9 9
Unintended Movement 9 9
Temperature Problem 8 8
Ambient Noise Problem 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Use of Incorrect Control Settings 7 7
Failure to Charge 6 6
Electrical /Electronic Property Problem 6 6
Stretched 6 6
Electrical Shorting 6 6
Operating System Becomes Nonfunctional 5 5
Mechanical Problem 5 5
Material Fragmentation 5 5
Contamination 5 5
No Display/Image 5 5
Intermittent Energy Output 5 5
Decoupling 4 4
Labelling, Instructions for Use or Training Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4800 4800
No Clinical Signs, Symptoms or Conditions 1759 1759
Unspecified Infection 1471 1472
Shaking/Tremors 1409 1410
Complaint, Ill-Defined 1389 1389
Therapeutic Effects, Unexpected 1236 1236
Therapeutic Response, Decreased 1059 1059
No Consequences Or Impact To Patient 988 988
Inadequate Pain Relief 773 773
Electric Shock 760 760
Ambulation Difficulties 750 750
Pain 497 498
Dysphasia 478 479
Cognitive Changes 447 447
Insufficient Information 421 421
Erosion 410 410
Fall 352 352
Discomfort 306 306
Muscular Rigidity 305 305
No Code Available 298 298
Undesired Nerve Stimulation 288 288
Tingling 266 266
Stroke/CVA 255 255
Intracranial Hemorrhage 220 220
Dyskinesia 207 207
Seizures 206 206
Post Operative Wound Infection 199 199
Neurological Deficit/Dysfunction 195 195
Headache 157 157
Erythema 156 156
Wound Dehiscence 145 145
Burning Sensation 133 133
Swelling 129 129
Bacterial Infection 122 122
Purulent Discharge 121 121
Confusion/ Disorientation 121 121
Pocket Erosion 118 118
Device Overstimulation of Tissue 117 117
Dizziness 114 114
Hematoma 113 113
Numbness 110 111
Anxiety 104 104
Sleep Dysfunction 95 95
Fatigue 95 95
Fluid Discharge 93 93
Scar Tissue 92 92
Staphylococcus Aureus 91 91
Loss of consciousness 89 89
Impaired Healing 87 87
Skin Erosion 86 86
Weakness 84 84
Muscle Spasm(s) 84 84
Muscle Weakness 84 84
Hemorrhage/Bleeding 79 79
Edema 78 78
Depression 77 77
Dysphagia/ Odynophagia 74 74
Death 71 71
Swelling/ Edema 70 70
Emotional Changes 68 68
Injury 65 65
Malaise 65 65
Neck Stiffness 64 64
Memory Loss/Impairment 63 63
Inflammation 62 62
Twitching 62 62
Bone Fracture(s) 61 61
Weight Changes 57 57
Paresthesia 57 57
Failure of Implant 56 56
Irritability 55 55
Hemorrhage, Cerebral 53 53
Foreign Body Reaction 53 53
Dementia 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Convulsion/Seizure 45 45
Paresis 45 45
Fever 42 42
Visual Impairment 42 42
Twiddlers Syndrome 42 42
Neck Pain 38 38
Dyspnea 37 37
Alteration In Body Temperature 35 35
Seroma 34 34
Distress 34 34
Nausea 34 34
Paralysis 33 33
Hypersensitivity/Allergic reaction 33 33
Irritation 33 33
Incontinence 33 33
Abscess 33 33
Adhesion(s) 32 32
Bruise/Contusion 32 32
High Blood Pressure/ Hypertension 31 31
Test Result 31 31
Cramp(s) /Muscle Spasm(s) 31 31
Hemorrhage, Subdural 30 30
Visual Disturbances 30 30
Tissue Breakdown 29 29
Lethargy 27 27

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Dec-27-2021
2 Medtronic Neuromodulation II Nov-24-2021
3 Medtronic Neuromodulation II Nov-04-2021
4 Medtronic Neuromodulation II Apr-07-2021
5 Medtronic Neuromodulation II Dec-16-2020
6 Medtronic Neuromodulation II Aug-23-2017
7 St. Jude Medical, Inc. II Dec-10-2018
8 St. Jude Medical, Inc. II Oct-17-2017
9 St. Jude Medical, Inc. II Jul-07-2017
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