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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted subcortical electrical stimulator (motor disorders)
Product CodeMRU
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 143 144
2022 167 171
2023 306 308
2024 266 266
2025 218 218
2026 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 250 250
Material Integrity Problem 223 223
Adverse Event Without Identified Device or Use Problem 192 192
Battery Problem 175 176
High impedance 162 163
Charging Problem 160 160
Failure to Deliver Energy 137 138
Insufficient Device Problem Information 101 101
Communication or Transmission Problem 82 82
Break 58 58
Improper or Incorrect Procedure or Method 57 58
Impedance Problem 52 52
Low impedance 49 49
Failure to Power Up 42 42
Migration or Expulsion of Device 41 41
Inappropriate/Inadequate Shock/Stimulation 41 41
Display or Visual Feedback Problem 39 39
Malposition of Device 39 39
Failure to Interrogate 38 38
Delayed Charge Time 35 35
Electromagnetic Compatibility Problem 31 31
Therapeutic or Diagnostic Output Failure 29 29
Overheating of Device 27 27
Energy Output Problem 25 25
Patient Device Interaction Problem 23 23
Material Frayed 20 20
Unintended Collision 19 19
Intermittent Continuity 19 19
Premature Discharge of Battery 17 17
Electromagnetic Interference 16 16
Unstable 13 13
No Device Output 12 12
Material Deformation 12 12
Data Problem 11 13
Application Program Problem 10 10
Operating System Becomes Nonfunctional 10 10
Loss of Data 10 10
Positioning Problem 9 9
Difficult to Remove 7 7
Disconnection 5 5
Material Twisted/Bent 5 6
Device Contamination with Chemical or Other Material 4 4
Degraded 4 4
Extracardiac stimulation 4 4
Human-Device Interface Problem 4 4
Power Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Difficult to Program or Calibrate 3 3
Therapy Delivered to Incorrect Body Area 3 3
Difficult to Open or Close 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 782 786
Insufficient Information 205 208
Unspecified Infection 75 75
Unspecified Nervous System Problem 56 56
Pain 53 53
Electric Shock 43 43
Dysphasia 34 34
Discomfort 31 31
Ambulation or Postural Difficulties 29 29
Shaking/Tremors 23 23
Cramp(s) /Muscle Spasm(s) 21 21
Burning Sensation 21 21
Muscular Rigidity 20 20
Convulsion/Seizure 17 17
Swelling/ Edema 15 16
Headache 15 15
Cognitive Changes 13 13
Erosion 12 12
Scar Tissue 11 11
Erythema 10 10
Neck Stiffness 9 9
Fall 9 9
Intracranial Hemorrhage 9 9
Bacterial Infection 8 8
Paresthesia 7 7
Foreign Body Reaction 7 7
Pocket Erosion 7 7
Purulent Discharge 6 6
Malaise 6 6
Fluid Discharge 6 6
Fatigue 6 6
Dizziness 6 6
Visual Impairment 6 6
Seroma 6 6
Adhesion(s) 6 6
Sleep Dysfunction 6 6
Wound Dehiscence 5 5
Dyspnea 5 5
Nausea 4 4
Device Embedded In Tissue or Plaque 4 4
Dyskinesia 4 4
Hypersensitivity/Allergic reaction 4 4
Muscle Weakness/Atrophy 4 4
Abscess 4 4
Post Operative Wound Infection 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Paresis 3 3
Visual Disturbances 3 3
Impaired Healing 3 3
Skin Inflammation/ Irritation 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II May-24-2022
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