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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 33

MDR Year MDR Reports MDR Events
2017 3560 3560
2018 4494 4494
2019 2818 2818
2020 2674 2674
2021 2431 2431
2022 1861 1861

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4444 4444
High impedance 2651 2651
Battery Problem 1743 1743
Failure to Deliver Energy 1373 1373
Device Operates Differently Than Expected 1264 1264
Charging Problem 1199 1199
Insufficient Information 1186 1186
Low impedance 1085 1085
Communication or Transmission Problem 954 954
Break 920 920
Component Misassembled 827 827
Inappropriate/Inadequate Shock/Stimulation 807 807
Unintended Collision 574 574
Energy Output Problem 557 557
Premature Discharge of Battery 503 503
Electromagnetic Compatibility Problem 478 478
Device Displays Incorrect Message 456 456
Migration or Expulsion of Device 449 449
Malposition of Device 429 429
Impedance Problem 401 401
Delayed Charge Time 395 395
Therapeutic or Diagnostic Output Failure 346 346
Failure to Interrogate 331 331
Low Battery 318 318
Improper or Incorrect Procedure or Method 306 306
Therapy Delivered to Incorrect Body Area 273 273
Connection Problem 263 263
Electromagnetic Interference 243 243
Unstable 237 237
Material Deformation 227 227
Intermittent Continuity 216 216
Shipping Damage or Problem 193 193
Patient Device Interaction Problem 155 155
Display or Visual Feedback Problem 145 145
Premature Elective Replacement Indicator 144 144
Data Problem 122 122
Material Integrity Problem 119 119
Fracture 117 117
Material Twisted/Bent 115 115
No Device Output 106 106
Overheating of Device 103 103
Loss of Data 98 98
Migration 92 92
Pocket Stimulation 88 88
Wireless Communication Problem 88 88
Positioning Problem 87 87
Unexpected Therapeutic Results 77 77
Use of Device Problem 72 72
Appropriate Term/Code Not Available 65 65
Device Contamination with Chemical or Other Material 64 64
Difficult to Open or Close 59 59
Disconnection 56 56
Activation, Positioning or Separation Problem 50 50
Incorrect, Inadequate or Imprecise Result or Readings 47 47
Bent 43 43
Device Or Device Fragments Location Unknown 40 40
Failure to Power Up 37 37
Human-Device Interface Problem 35 35
Device Difficult to Program or Calibrate 29 29
No Apparent Adverse Event 28 28
Environmental Compatibility Problem 28 28
Difficult to Remove 26 26
Difficult to Insert 24 24
Energy Output To Patient Tissue Incorrect 23 23
Device Markings/Labelling Problem 23 23
Component Missing 22 22
Application Program Problem 21 21
Defective Device 19 19
Inadequacy of Device Shape and/or Size 17 17
Unable to Obtain Readings 16 16
Peeled/Delaminated 15 15
Device Damaged by Another Device 14 14
Failure to Advance 14 14
Improper Device Output 14 14
Unintended Movement 13 13
Electro-Static Discharge 13 13
Patient-Device Incompatibility 13 13
Noise, Audible 12 12
Vibration 12 12
Material Frayed 12 12
Shelf Life Exceeded 11 11
Degraded 10 10
Device Inoperable 9 9
Loss of Power 9 9
Use of Incorrect Control/Treatment Settings 8 8
Temperature Problem 8 8
Ambient Noise Problem 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Intermittent Energy Output 6 6
Electrical Shorting 6 6
Failure to Charge 6 6
Material Fragmentation 6 6
Electrical /Electronic Property Problem 6 6
Stretched 6 6
Mechanical Problem 5 5
Contamination 5 5
No Display/Image 5 5
Operating System Becomes Nonfunctional 5 5
Power Problem 4 4
Inadequate Instructions for Non-Healthcare Professional 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 2268 2268
Unspecified Infection 1564 1565
Shaking/Tremors 1474 1475
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 894 894
Electric Shock 790 790
Ambulation Difficulties 781 781
Insufficient Information 553 553
Pain 522 523
Dysphasia 501 502
Cognitive Changes 469 469
Erosion 439 439
Fall 366 366
Muscular Rigidity 324 324
Discomfort 322 322
No Code Available 298 298
Undesired Nerve Stimulation 291 291
Tingling 266 266
Stroke/CVA 260 260
Intracranial Hemorrhage 243 243
Post Operative Wound Infection 222 222
Dyskinesia 217 217
Seizures 206 206
Neurological Deficit/Dysfunction 195 195
Headache 174 174
Erythema 166 166
Wound Dehiscence 155 155
Burning Sensation 142 142
Bacterial Infection 140 140
Confusion/ Disorientation 131 131
Swelling 129 129
Hematoma 126 126
Pocket Erosion 125 125
Purulent Discharge 125 125
Device Overstimulation of Tissue 119 119
Dizziness 117 117
Numbness 110 111
Anxiety 109 109
Sleep Dysfunction 101 101
Fatigue 99 99
Fluid Discharge 97 97
Loss of consciousness 95 95
Scar Tissue 95 95
Staphylococcus Aureus 91 91
Muscle Weakness 91 91
Skin Erosion 91 91
Swelling/ Edema 91 91
Impaired Healing 90 90
Hemorrhage/Bleeding 89 89
Muscle Spasm(s) 84 84
Weakness 84 84
Depression 82 82
Dysphagia/ Odynophagia 81 81
Failure of Implant 79 79
Edema 78 78
Emotional Changes 75 75
Death 71 71
Inflammation 67 67
Malaise 67 67
Paresthesia 67 67
Convulsion/Seizure 66 66
Injury 65 65
Neck Stiffness 64 64
Memory Loss/Impairment 64 64
Twitching 63 63
Bone Fracture(s) 62 62
Foreign Body Reaction 58 58
Weight Changes 57 57
Irritability 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Dementia 53 53
Hemorrhage, Cerebral 53 53
Paresis 49 49
Visual Impairment 47 47
Fever 45 45
Twiddlers Syndrome 42 42
Neck Pain 38 38
Dyspnea 38 38
Nausea 37 37
Seroma 36 36
Alteration In Body Temperature 35 35
Distress 34 34
Paralysis 34 34
Incontinence 34 34
Hypersensitivity/Allergic reaction 34 34
Abscess 34 34
Adhesion(s) 34 34
Bruise/Contusion 33 33
Irritation 33 33
Cramp(s) /Muscle Spasm(s) 32 32
Test Result 31 31
Unspecified Nervous System Problem 31 31
High Blood Pressure/ Hypertension 31 31
Visual Disturbances 31 31
Tissue Breakdown 30 30
Hemorrhage, Subdural 30 30

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II May-24-2022
2 Medtronic Neuromodulation II Dec-27-2021
3 Medtronic Neuromodulation II Nov-24-2021
4 Medtronic Neuromodulation II Nov-04-2021
5 Medtronic Neuromodulation II Apr-07-2021
6 Medtronic Neuromodulation II Dec-16-2020
7 Medtronic Neuromodulation II Aug-23-2017
8 St. Jude Medical, Inc. II Dec-10-2018
9 St. Jude Medical, Inc. II Oct-17-2017
10 St. Jude Medical, Inc. II Jul-07-2017
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