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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)
2018 2019 2020 2021 2022 2023
36 42 37 36 34 22

MDR Year MDR Reports MDR Events
2018 4494 4494
2019 2818 2818
2020 2674 2674
2021 2426 2426
2022 2257 2257
2023 1586 1586

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4110 4110
High impedance 2480 2480
Battery Problem 1809 1809
Insufficient Information 1345 1345
Failure to Deliver Energy 1198 1198
Charging Problem 1012 1012
Low impedance 917 917
Communication or Transmission Problem 859 859
Component Misassembled 827 827
Break 793 793
Inappropriate/Inadequate Shock/Stimulation 679 679
Energy Output Problem 585 585
Unintended Collision 452 452
Electromagnetic Compatibility Problem 425 425
Premature Discharge of Battery 420 420
Device Operates Differently Than Expected 412 412
Migration or Expulsion of Device 402 402
Therapeutic or Diagnostic Output Failure 388 388
Impedance Problem 381 381
Malposition of Device 376 376
Failure to Interrogate 324 324
Delayed Charge Time 320 320
Improper or Incorrect Procedure or Method 318 318
Connection Problem 234 234
Unstable 206 206
Material Deformation 194 194
Electromagnetic Interference 190 190
Therapy Delivered to Incorrect Body Area 179 179
Patient Device Interaction Problem 173 173
Device Displays Incorrect Message 167 167
Shipping Damage or Problem 157 157
Material Twisted/Bent 150 150
Fracture 140 140
Intermittent Continuity 133 133
Data Problem 133 133
Wireless Communication Problem 121 121
Migration 115 115
Display or Visual Feedback Problem 108 108
Premature Elective Replacement Indicator 106 106
Overheating of Device 105 105
Low Battery 102 102
Loss of Data 99 99
Material Integrity Problem 91 91
Positioning Problem 85 85
No Device Output 84 84
Use of Device Problem 80 80
Unexpected Therapeutic Results 79 79
Difficult to Open or Close 69 69
Pocket Stimulation 65 65
Appropriate Term/Code Not Available 61 61
Disconnection 50 50
Device Contamination with Chemical or Other Material 49 49
Application Program Problem 46 46
No Apparent Adverse Event 43 43
Incorrect, Inadequate or Imprecise Result or Readings 41 41
Failure to Power Up 39 39
Activation, Positioning or Separation Problem 39 39
Human-Device Interface Problem 33 33
Difficult to Insert 30 30
Difficult to Remove 29 29
Component Missing 29 29
Device Markings/Labelling Problem 27 27
Device Difficult to Program or Calibrate 24 24
Environmental Compatibility Problem 20 20
Defective Device 19 19
Device Or Device Fragments Location Unknown 17 17
Failure to Advance 16 16
Inadequacy of Device Shape and/or Size 15 15
Unable to Obtain Readings 14 14
Electro-Static Discharge 14 14
Patient-Device Incompatibility 13 13
Peeled/Delaminated 13 13
Bent 13 13
Material Frayed 12 12
Device Damaged by Another Device 12 12
Unintended Movement 11 11
Noise, Audible 11 11
Degraded 10 10
Vibration 10 10
Loss of Power 9 9
Use of Incorrect Control/Treatment Settings 8 8
Energy Output To Patient Tissue Incorrect 8 8
Temperature Problem 8 8
Operating System Becomes Nonfunctional 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Improper Device Output 7 7
Electrical Shorting 6 6
Electrical /Electronic Property Problem 6 6
Material Fragmentation 6 6
Failure to Charge 6 6
Intermittent Energy Output 6 6
Unexpected Shutdown 5 5
No Display/Image 5 5
Mechanical Problem 5 5
Ambient Noise Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Power Problem 4 4
Unauthorized Access to Computer System 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Device Contaminated During Manufacture or Shipping 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3423 3423
No Clinical Signs, Symptoms or Conditions 3165 3165
Unspecified Infection 1466 1467
Shaking/Tremors 1204 1205
Inadequate Pain Relief 1069 1069
No Consequences Or Impact To Patient 988 988
Complaint, Ill-Defined 893 893
Insufficient Information 789 789
Therapeutic Response, Decreased 750 750
Therapeutic Effects, Unexpected 698 698
Electric Shock 660 660
Ambulation Difficulties 651 651
Erosion 435 435
Pain 427 428
Dysphasia 391 392
Cognitive Changes 387 387
Fall 328 328
No Code Available 291 291
Discomfort 281 281
Muscular Rigidity 263 263
Intracranial Hemorrhage 229 229
Undesired Nerve Stimulation 210 210
Stroke/CVA 207 207
Post Operative Wound Infection 203 203
Tingling 179 179
Wound Dehiscence 176 176
Dyskinesia 163 163
Headache 157 157
Bacterial Infection 144 144
Seizures 144 144
Failure of Implant 140 140
Erythema 139 139
Neurological Deficit/Dysfunction 131 131
Burning Sensation 129 129
Pocket Erosion 126 126
Swelling/ Edema 126 126
Confusion/ Disorientation 121 121
Purulent Discharge 120 120
Hematoma 112 112
Swelling 102 102
Device Overstimulation of Tissue 96 96
Dizziness 96 96
Numbness 92 93
Skin Erosion 92 92
Impaired Healing 91 91
Fluid Discharge 90 90
Convulsion/Seizure 86 86
Paresthesia 85 85
Muscle Weakness 85 85
Loss of consciousness 82 82
Sleep Dysfunction 80 80
Scar Tissue 80 80
Hemorrhage/Bleeding 76 76
Movement Disorder 74 74
Depression 72 72
Anxiety 70 70
Emotional Changes 69 69
Fatigue 69 69
Inflammation 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 63 63
Staphylococcus Aureus 60 60
Weakness 60 60
Edema 58 58
Muscle Spasm(s) 57 57
Neck Stiffness 57 57
Dysphagia/ Odynophagia 55 55
Bone Fracture(s) 53 53
Weight Changes 50 50
Malaise 50 50
Twitching 45 45
Memory Loss/Impairment 45 45
Cramp(s) /Muscle Spasm(s) 44 44
Unspecified Nervous System Problem 42 42
Injury 41 41
Implant Pain 41 41
Irritability 40 40
Visual Impairment 40 40
Hemorrhage, Cerebral 39 39
Death 39 39
Dyspnea 38 38
Foreign Body Reaction 38 38
Paresis 38 38
Fever 36 36
Twiddlers Syndrome 36 36
Neck Pain 36 36
Abscess 34 34
Nausea 33 33
Hypersensitivity/Allergic reaction 32 32
Seroma 32 32
Adhesion(s) 32 32
Paralysis 30 30
High Blood Pressure/ Hypertension 28 28
Alteration In Body Temperature 26 26
Twiddlers Syndrome 26 26
Device Embedded In Tissue or Plaque 25 25
Hemorrhage, Subdural 24 24
Bruise/Contusion 23 23
Irritation 23 23
Visual Disturbances 23 23
Tissue Breakdown 22 22

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Apr-19-2023
2 Medtronic Neuromodulation II May-24-2022
3 Medtronic Neuromodulation II Dec-27-2021
4 Medtronic Neuromodulation II Nov-24-2021
5 Medtronic Neuromodulation II Nov-04-2021
6 Medtronic Neuromodulation II Apr-07-2021
7 Medtronic Neuromodulation II Dec-16-2020
8 St. Jude Medical, Inc. II Dec-10-2018
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