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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)
2019 2020 2021 2022 2023 2024
42 37 36 34 31 10

MDR Year MDR Reports MDR Events
2019 2818 2818
2020 2674 2674
2021 2426 2426
2022 2257 2257
2023 3495 3495
2024 1802 1802

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3620 3620
High impedance 2101 2101
Connection Problem 1902 1902
Battery Problem 1700 1700
Material Integrity Problem 1624 1624
Insufficient Information 1290 1290
Charging Problem 1166 1166
Failure to Deliver Energy 1032 1032
Low impedance 765 765
Communication or Transmission Problem 730 730
Break 657 657
Inappropriate/Inadequate Shock/Stimulation 565 565
Failure to Power Up 548 548
Energy Output Problem 437 437
Impedance Problem 376 376
Therapeutic or Diagnostic Output Failure 363 363
Electromagnetic Compatibility Problem 337 337
Migration or Expulsion of Device 333 333
Failure to Interrogate 317 317
Premature Discharge of Battery 317 317
Malposition of Device 310 310
Improper or Incorrect Procedure or Method 299 299
Unintended Collision 296 296
Delayed Charge Time 244 244
Unstable 183 183
Display or Visual Feedback Problem 168 168
Material Deformation 165 165
Patient Device Interaction Problem 161 161
Material Twisted/Bent 158 158
Material Frayed 148 148
Wireless Communication Problem 137 137
Fracture 136 136
Electromagnetic Interference 134 134
Overheating of Device 130 130
Shipping Damage or Problem 121 121
Data Problem 120 120
Migration 117 117
Therapy Delivered to Incorrect Body Area 115 115
Intermittent Continuity 111 111
Loss of Data 100 100
Positioning Problem 81 81
Use of Device Problem 76 76
Unexpected Therapeutic Results 71 71
Difficult to Open or Close 68 68
Application Program Problem 59 59
No Device Output 57 57
No Apparent Adverse Event 49 49
Disconnection 44 44
Pocket Stimulation 42 42
Operating System Becomes Nonfunctional 41 41
Device Contamination with Chemical or Other Material 39 39
Human-Device Interface Problem 33 33
Premature Elective Replacement Indicator 30 30
Difficult to Remove 28 28
Difficult to Insert 27 27
Activation, Positioning or Separation Problem 27 27
Device Markings/Labelling Problem 27 27
Component Missing 26 26
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Noise, Audible 22 22
Device Difficult to Program or Calibrate 20 20
Mechanical Problem 20 20
Vibration 18 18
Unintended Movement 17 17
Failure to Advance 16 16
Unable to Obtain Readings 16 16
Environmental Compatibility Problem 14 14
Inadequacy of Device Shape and/or Size 13 13
Defective Device 13 13
Degraded 12 12
Electro-Static Discharge 11 11
Appropriate Term/Code Not Available 11 11
Contamination 10 10
Device Damaged by Another Device 9 9
Audible Prompt/Feedback Problem 9 9
Corroded 8 8
Material Fragmentation 8 8
Peeled/Delaminated 8 8
Unsealed Device Packaging 7 7
Intermittent Energy Output 6 6
Temperature Problem 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Unexpected Shutdown 5 5
Device Displays Incorrect Message 5 5
Ambient Noise Problem 5 5
Use of Incorrect Control/Treatment Settings 4 4
Failure to Charge 4 4
Mechanical Jam 4 4
Unauthorized Access to Computer System 4 4
Device Contaminated During Manufacture or Shipping 4 4
Power Problem 3 3
Component Misassembled 3 3
Material Split, Cut or Torn 3 3
Failure to Disconnect 3 3
Separation Failure 2 2
Patient-Device Incompatibility 2 2
Structural Problem 2 2
Premature End-of-Life Indicator 2 2
Off-Label Use 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6098 6098
No Known Impact Or Consequence To Patient 1927 1927
Unspecified Infection 1353 1353
Inadequate Pain Relief 1016 1016
Insufficient Information 964 964
Shaking/Tremors 917 917
Electric Shock 548 548
Ambulation Difficulties 493 493
Complaint, Ill-Defined 459 459
Therapeutic Response, Decreased 407 407
Erosion 391 391
Pain 326 326
Therapeutic Effects, Unexpected 311 311
Cognitive Changes 289 289
Dysphasia 276 276
Fall 252 252
Discomfort 229 229
Failure of Implant 225 225
Post Operative Wound Infection 207 207
Muscular Rigidity 204 204
Intracranial Hemorrhage 202 202
No Code Available 192 192
Movement Disorder 179 179
Wound Dehiscence 165 165
Swelling/ Edema 147 147
Undesired Nerve Stimulation 138 138
Bacterial Infection 133 133
Stroke/CVA 132 132
No Consequences Or Impact To Patient 131 131
Headache 125 125
Burning Sensation 116 116
Purulent Discharge 115 115
Dyskinesia 110 110
Erythema 108 108
Convulsion/Seizure 106 106
Pocket Erosion 103 103
Paresthesia 101 101
Hematoma 98 98
Tingling 92 92
Confusion/ Disorientation 88 88
Fluid Discharge 84 84
Skin Erosion 78 78
Device Overstimulation of Tissue 78 78
Muscle Weakness 73 73
Impaired Healing 71 71
Seizures 69 69
Scar Tissue 68 68
Loss of consciousness 68 68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 68 68
Numbness 65 65
Hemorrhage/Bleeding 61 61
Sleep Dysfunction 60 60
Fatigue 58 58
Implant Pain 56 56
Unspecified Nervous System Problem 55 55
Swelling 55 55
Inflammation 54 54
Cramp(s) /Muscle Spasm(s) 54 54
Dizziness 52 52
Neurological Deficit/Dysfunction 52 52
Depression 48 48
Emotional Changes 46 46
Dysphagia/ Odynophagia 46 46
Anxiety 42 42
Malaise 37 37
Bone Fracture(s) 37 37
Neck Stiffness 35 35
Weight Changes 35 35
Twiddlers Syndrome 33 33
Visual Impairment 33 33
Paresis 32 32
Memory Loss/Impairment 32 32
Fever 32 32
Twitching 32 32
Edema 31 31
Hypersensitivity/Allergic reaction 30 30
Nausea 30 30
Paralysis 30 30
Foreign Body Reaction 29 29
Adhesion(s) 29 29
Dyspnea 27 27
Death 27 27
Twiddlers Syndrome 27 27
Seroma 27 27
Weakness 27 27
Irritability 26 26
Staphylococcus Aureus 26 26
Muscle Spasm(s) 26 26
Abscess 26 26
Lethargy 25 25
Suicidal Ideation 24 24
Hemorrhage, Cerebral 24 24
Neck Pain 23 23
Hallucination 22 22
Unspecified Tissue Injury 22 22
High Blood Pressure/ Hypertension 20 20
Visual Disturbances 19 19
Device Embedded In Tissue or Plaque 18 18
Speech Disorder 17 17
Tissue Breakdown 17 17

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Nov-03-2023
2 Medtronic Neuromodulation II Oct-18-2023
3 Medtronic Neuromodulation II Apr-19-2023
4 Medtronic Neuromodulation II May-24-2022
5 Medtronic Neuromodulation II Dec-27-2021
6 Medtronic Neuromodulation II Nov-24-2021
7 Medtronic Neuromodulation II Nov-04-2021
8 Medtronic Neuromodulation II Apr-07-2021
9 Medtronic Neuromodulation II Dec-16-2020
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