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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)
2020 2021 2022 2023 2024 2025
37 36 34 31 47 37

MDR Year MDR Reports MDR Events
2020 2673 2673
2021 2426 2427
2022 2257 2258
2023 3489 3489
2024 4379 4379
2025 2850 2850

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3894 3894
High impedance 2484 2484
Connection Problem 2391 2391
Battery Problem 2192 2192
Material Integrity Problem 2085 2085
Insufficient Information 1434 1434
Charging Problem 1324 1324
Failure to Deliver Energy 1149 1149
Communication or Transmission Problem 849 849
Low impedance 736 736
Break 724 724
Failure to Power Up 697 697
Inappropriate/Inadequate Shock/Stimulation 555 555
Impedance Problem 496 496
Failure to Interrogate 423 423
Therapeutic or Diagnostic Output Failure 416 416
Display or Visual Feedback Problem 412 412
Energy Output Problem 375 375
Migration or Expulsion of Device 371 372
Electromagnetic Compatibility Problem 355 355
Improper or Incorrect Procedure or Method 348 348
Malposition of Device 284 284
Premature Discharge of Battery 277 278
Unintended Collision 268 268
Delayed Charge Time 263 263
Material Twisted/Bent 239 239
Unstable 203 203
Material Deformation 201 201
Wireless Communication Problem 184 184
Fracture 184 184
Migration 178 178
Material Frayed 173 173
Overheating of Device 165 165
Unexpected Therapeutic Results 151 151
Patient Device Interaction Problem 147 147
Data Problem 141 141
Operating System Becomes Nonfunctional 137 137
Intermittent Continuity 133 133
Electromagnetic Interference 130 130
Use of Device Problem 120 120
Loss of Data 104 104
Therapy Delivered to Incorrect Body Area 100 100
Difficult to Open or Close 97 97
No Apparent Adverse Event 95 95
Unintended Application Program Shut Down 81 81
Positioning Problem 79 79
Shipping Damage or Problem 79 79
Application Program Problem 69 69
No Device Output 53 53
Difficult to Remove 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9096 9096
Insufficient Information 1480 1480
Unspecified Infection 1384 1384
Inadequate Pain Relief 971 971
Shaking/Tremors 896 897
No Known Impact Or Consequence To Patient 856 856
Failure of Implant 800 801
Movement Disorder 754 754
Electric Shock 518 518
Ambulation Difficulties 479 479
Erosion 441 441
Pain 358 358
Discomfort 269 269
Cognitive Changes 260 260
Dysphasia 255 255
Fall 249 249
Post Operative Wound Infection 245 245
Intracranial Hemorrhage 224 224
Swelling/ Edema 223 223
Wound Dehiscence 202 202
Muscular Rigidity 195 195
Complaint, Ill-Defined 192 192
Therapeutic Response, Decreased 190 190
Bacterial Infection 163 163
Undesired Nerve Stimulation 157 157
Convulsion/Seizure 143 143
Burning Sensation 142 142
Paresthesia 137 137
Therapeutic Effects, Unexpected 130 130
Erythema 130 130
Purulent Discharge 126 126
Headache 125 125
Dyskinesia 122 122
Implant Pain 112 112
Fluid Discharge 106 106
Stroke/CVA 105 105
No Code Available 104 104
Pocket Erosion 102 102
Hematoma 97 97
Confusion/ Disorientation 96 96
Muscle Weakness 95 95
Skin Erosion 88 88
Scar Tissue 85 85
Unspecified Nervous System Problem 84 84
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
Impaired Healing 81 81
Loss of consciousness 79 79
Cramp(s) /Muscle Spasm(s) 77 77
No Consequences Or Impact To Patient 73 73
Device Overstimulation of Tissue 73 73

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
14 Medtronic Neuromodulation II Dec-16-2020
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