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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 46 0

MDR Year MDR Reports MDR Events
2020 2674 2674
2021 2426 2426
2022 2258 2258
2023 3495 3495
2024 4383 4383

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3310 3310
Connection Problem 2133 2133
High impedance 2043 2043
Material Integrity Problem 1849 1849
Battery Problem 1783 1783
Insufficient Information 1191 1191
Charging Problem 1148 1148
Failure to Deliver Energy 981 981
Communication or Transmission Problem 718 718
Failure to Power Up 678 678
Low impedance 656 656
Break 626 626
Inappropriate/Inadequate Shock/Stimulation 468 468
Impedance Problem 395 395
Failure to Interrogate 342 342
Therapeutic or Diagnostic Output Failure 320 320
Migration or Expulsion of Device 318 318
Energy Output Problem 314 314
Electromagnetic Compatibility Problem 301 301
Improper or Incorrect Procedure or Method 294 294
Malposition of Device 251 251
Premature Discharge of Battery 247 247
Display or Visual Feedback Problem 239 239
Delayed Charge Time 227 227
Unintended Collision 221 221
Material Twisted/Bent 194 194
Unstable 178 178
Material Deformation 165 165
Material Frayed 161 161
Wireless Communication Problem 157 157
Fracture 154 154
Migration 150 150
Overheating of Device 143 143
Patient Device Interaction Problem 138 138
Data Problem 121 121
Intermittent Continuity 105 105
Electromagnetic Interference 102 102
Loss of Data 95 95
Use of Device Problem 93 93
Therapy Delivered to Incorrect Body Area 90 90
Unintended Application Program Shut Down 81 81
Difficult to Open or Close 80 80
Unexpected Therapeutic Results 75 75
Operating System Becomes Nonfunctional 75 75
Positioning Problem 71 71
No Apparent Adverse Event 70 70
Shipping Damage or Problem 69 69
Application Program Problem 63 63
No Device Output 48 48
Pocket Stimulation 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7539 7539
Unspecified Infection 1216 1216
Insufficient Information 1162 1162
Inadequate Pain Relief 920 920
No Known Impact Or Consequence To Patient 856 856
Shaking/Tremors 748 748
Failure of Implant 590 590
Movement Disorder 540 540
Electric Shock 449 449
Ambulation Difficulties 427 427
Erosion 372 372
Pain 303 303
Cognitive Changes 225 225
Dysphasia 224 224
Discomfort 220 220
Fall 220 220
Post Operative Wound Infection 206 206
Intracranial Hemorrhage 199 199
Complaint, Ill-Defined 192 192
Therapeutic Response, Decreased 190 190
Swelling/ Edema 179 179
Muscular Rigidity 168 168
Wound Dehiscence 153 153
Therapeutic Effects, Unexpected 130 130
Bacterial Infection 129 129
Convulsion/Seizure 125 125
Burning Sensation 123 123
Undesired Nerve Stimulation 120 120
Paresthesia 116 116
Headache 109 109
Purulent Discharge 105 105
Erythema 105 105
No Code Available 104 104
Dyskinesia 99 99
Stroke/CVA 90 90
Implant Pain 89 89
Pocket Erosion 86 86
Hematoma 85 85
Confusion/ Disorientation 83 83
Fluid Discharge 81 81
Muscle Weakness 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
No Consequences Or Impact To Patient 73 73
Skin Erosion 73 73
Scar Tissue 71 71
Unspecified Nervous System Problem 70 70
Device Overstimulation of Tissue 68 68
Loss of consciousness 66 66
Cramp(s) /Muscle Spasm(s) 65 65
Twiddlers Syndrome 64 64

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-25-2024
2 Abbott Medical II Jul-03-2024
3 Medtronic Neuromodulation II Oct-23-2024
4 Medtronic Neuromodulation II Jul-24-2024
5 Medtronic Neuromodulation II Nov-03-2023
6 Medtronic Neuromodulation II Oct-18-2023
7 Medtronic Neuromodulation II Apr-19-2023
8 Medtronic Neuromodulation II May-24-2022
9 Medtronic Neuromodulation II Dec-27-2021
10 Medtronic Neuromodulation II Nov-24-2021
11 Medtronic Neuromodulation II Nov-04-2021
12 Medtronic Neuromodulation II Apr-07-2021
13 Medtronic Neuromodulation II Dec-16-2020
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