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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 16

MDR Year MDR Reports MDR Events
2020 2674 2674
2021 2426 2426
2022 2258 2258
2023 3495 3495
2024 4379 4379
2025 1424 1424

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3599 3599
High impedance 2275 2275
Connection Problem 2267 2267
Battery Problem 2015 2015
Material Integrity Problem 1970 1970
Insufficient Information 1306 1306
Charging Problem 1229 1229
Failure to Deliver Energy 1065 1065
Communication or Transmission Problem 777 777
Low impedance 704 704
Failure to Power Up 691 691
Break 683 683
Inappropriate/Inadequate Shock/Stimulation 515 515
Impedance Problem 444 444
Failure to Interrogate 381 381
Therapeutic or Diagnostic Output Failure 373 373
Energy Output Problem 343 343
Migration or Expulsion of Device 338 338
Display or Visual Feedback Problem 332 332
Electromagnetic Compatibility Problem 328 328
Improper or Incorrect Procedure or Method 314 314
Malposition of Device 263 263
Premature Discharge of Battery 255 255
Unintended Collision 246 246
Delayed Charge Time 241 241
Material Twisted/Bent 211 211
Unstable 189 189
Material Deformation 181 181
Fracture 170 170
Wireless Communication Problem 167 167
Migration 166 166
Material Frayed 165 165
Overheating of Device 150 150
Patient Device Interaction Problem 145 145
Data Problem 131 131
Electromagnetic Interference 116 116
Intermittent Continuity 115 115
Use of Device Problem 108 108
Operating System Becomes Nonfunctional 104 104
Unexpected Therapeutic Results 101 101
Loss of Data 99 99
Therapy Delivered to Incorrect Body Area 96 96
Difficult to Open or Close 93 93
No Apparent Adverse Event 82 82
Unintended Application Program Shut Down 81 81
Positioning Problem 75 75
Shipping Damage or Problem 75 75
Application Program Problem 68 68
No Device Output 51 51
Difficult to Remove 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8319 8319
Insufficient Information 1312 1312
Unspecified Infection 1300 1300
Inadequate Pain Relief 941 941
No Known Impact Or Consequence To Patient 856 856
Shaking/Tremors 807 807
Failure of Implant 732 732
Movement Disorder 649 649
Electric Shock 487 487
Ambulation Difficulties 448 448
Erosion 403 403
Pain 331 331
Dysphasia 242 242
Cognitive Changes 242 242
Discomfort 240 240
Fall 234 234
Post Operative Wound Infection 224 224
Intracranial Hemorrhage 215 215
Swelling/ Edema 198 198
Complaint, Ill-Defined 192 192
Therapeutic Response, Decreased 190 190
Muscular Rigidity 181 181
Wound Dehiscence 181 181
Bacterial Infection 146 146
Undesired Nerve Stimulation 137 137
Burning Sensation 131 131
Convulsion/Seizure 130 130
Therapeutic Effects, Unexpected 130 130
Paresthesia 126 126
Headache 119 119
Purulent Discharge 118 118
Erythema 114 114
Dyskinesia 110 110
No Code Available 104 104
Implant Pain 104 104
Stroke/CVA 99 99
Hematoma 96 96
Pocket Erosion 94 94
Confusion/ Disorientation 93 93
Fluid Discharge 90 90
Muscle Weakness 85 85
Scar Tissue 80 80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Skin Erosion 76 76
Unspecified Nervous System Problem 74 74
Device Overstimulation of Tissue 73 73
Loss of consciousness 73 73
No Consequences Or Impact To Patient 73 73
Impaired Healing 71 71
Cramp(s) /Muscle Spasm(s) 70 70

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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