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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)
2021 2022 2023 2024 2025 2026
36 34 31 47 44 8

MDR Year MDR Reports MDR Events
2021 2427 2436
2022 2257 2265
2023 3489 3493
2024 4383 4390
2025 3424 3424
2026 782 782

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3462 3472
Connection Problem 2437 2438
High impedance 2330 2333
Material Integrity Problem 2143 2144
Battery Problem 2022 2025
Insufficient Information 1298 1298
Charging Problem 1218 1218
Failure to Deliver Energy 991 991
Communication or Transmission Problem 761 761
Failure to Power Up 711 711
Break 635 635
Low impedance 600 600
Impedance Problem 496 496
Display or Visual Feedback Problem 495 495
Inappropriate/Inadequate Shock/Stimulation 446 446
Failure to Interrogate 440 440
Therapeutic or Diagnostic Output Failure 348 348
Energy Output Problem 329 329
Migration or Expulsion of Device 323 324
Improper or Incorrect Procedure or Method 319 319
Electromagnetic Compatibility Problem 295 295
Malposition of Device 260 260
Premature Discharge of Battery 260 261
Material Twisted/Bent 233 234
Delayed Charge Time 220 220
Unintended Collision 218 218
Material Deformation 192 192
Unstable 184 184
Fracture 183 184
Wireless Communication Problem 182 182
Unexpected Therapeutic Results 180 182
Operating System Becomes Nonfunctional 176 176
Material Frayed 170 170
Migration 162 163
Overheating of Device 157 157
Intermittent Continuity 122 122
Use of Device Problem 121 121
Electromagnetic Interference 115 115
Patient Device Interaction Problem 112 112
Data Problem 110 110
No Apparent Adverse Event 107 108
Difficult to Open or Close 105 105
Loss of Data 87 87
Unintended Application Program Shut Down 81 87
Therapy Delivered to Incorrect Body Area 71 71
Positioning Problem 70 70
Application Program Problem 67 67
Difficult to Remove 53 53
Shipping Damage or Problem 46 46
No Device Output 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9616 9622
Insufficient Information 1559 1561
Unspecified Infection 1187 1188
Movement Disorder 846 854
Inadequate Pain Relief 814 819
Failure of Implant 793 802
Shaking/Tremors 761 762
Electric Shock 412 412
Ambulation Difficulties 401 401
Erosion 377 379
Pain 301 301
Post Operative Wound Infection 249 251
Discomfort 245 245
Fall 230 230
Swelling/ Edema 230 230
Cognitive Changes 210 210
Dysphasia 207 207
Intracranial Hemorrhage 201 201
Wound Dehiscence 184 184
Muscular Rigidity 174 174
Bacterial Infection 167 167
Convulsion/Seizure 155 155
Burning Sensation 133 133
Paresthesia 130 130
Implant Pain 128 128
Undesired Nerve Stimulation 124 124
Purulent Discharge 122 122
Erythema 122 122
Dyskinesia 100 100
Fluid Discharge 99 101
Headache 99 99
Unspecified Nervous System Problem 92 92
Hematoma 89 90
Stroke/CVA 86 86
Pocket Erosion 85 85
Muscle Weakness 84 84
Confusion/ Disorientation 81 81
Cramp(s) /Muscle Spasm(s) 80 80
Twiddlers Syndrome 78 78
Loss of consciousness 76 76
Impaired Healing 71 71
Skin Erosion 66 66
Inflammation 66 66
Scar Tissue 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 62 62
Hemorrhage/Bleeding 61 61
Dizziness 53 53
Numbness 53 53
Device Overstimulation of Tissue 45 45
Dysphagia/ Odynophagia 45 45

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Nov-07-2025
2 Abbott Medical II Jul-25-2024
3 Abbott Medical II Jul-03-2024
4 Medtronic Neuromodulation II Oct-23-2024
5 Medtronic Neuromodulation II Jul-24-2024
6 Medtronic Neuromodulation II Nov-03-2023
7 Medtronic Neuromodulation II Oct-18-2023
8 Medtronic Neuromodulation II Apr-19-2023
9 Medtronic Neuromodulation II May-24-2022
10 Medtronic Neuromodulation II Dec-27-2021
11 Medtronic Neuromodulation II Nov-24-2021
12 Medtronic Neuromodulation II Nov-04-2021
13 Medtronic Neuromodulation II Apr-07-2021
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