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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
2014 246 246
2015 301 301
2016 299 299
2017 163 163
2018 61 61
2019 198 198
2020 133 133
2021 143 143
2022 169 169
2023 305 305
2024 139 139

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 460 460
High impedance 284 284
Battery Problem 238 238
Device Operates Differently Than Expected 233 233
Charging Problem 226 226
Failure to Deliver Energy 207 207
Connection Problem 204 204
Material Integrity Problem 169 169
Communication or Transmission Problem 145 145
Break 129 129
Low impedance 123 123
Migration or Expulsion of Device 106 106
Insufficient Information 103 103
Inappropriate/Inadequate Shock/Stimulation 99 99
Device Displays Incorrect Message 87 87
Malposition of Device 85 85
Improper or Incorrect Procedure or Method 72 72
Impedance Problem 72 72
Low Battery 71 71
Electromagnetic Compatibility Problem 66 66
Premature Discharge of Battery 60 60
Delayed Charge Time 48 48
Intermittent Continuity 46 46
Unintended Collision 46 46
Failure to Interrogate 39 39
Electromagnetic Interference 38 38
Failure to Power Up 37 37
Energy Output Problem 33 33
Overheating of Device 30 30
Unstable 28 28
Patient Device Interaction Problem 27 27
Display or Visual Feedback Problem 20 20
Therapy Delivered to Incorrect Body Area 19 19
Material Deformation 18 18
Therapeutic or Diagnostic Output Failure 18 18
Pocket Stimulation 17 17
Material Frayed 17 17
Positioning Problem 14 14
Data Problem 14 14
No Device Output 11 11
Loss of Data 11 11
Application Program Problem 10 10
Unexpected Therapeutic Results 9 9
Device Or Device Fragments Location Unknown 7 7
Inadequacy of Device Shape and/or Size 6 6
Unable to Obtain Readings 6 6
Electro-Static Discharge 5 5
Use of Device Problem 4 4
Device Difficult to Program or Calibrate 4 4
Shelf Life Exceeded 4 4
Compatibility Problem 4 4
Material Twisted/Bent 4 4
Environmental Compatibility Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Difficult to Remove 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Power Problem 4 4
Unauthorized Access to Computer System 3 3
Unintended Movement 3 3
Appropriate Term/Code Not Available 3 3
Noise, Audible 3 3
Nonstandard Device 3 3
Disconnection 3 3
Use of Incorrect Control/Treatment Settings 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged by Another Device 3 3
Shipping Damage or Problem 2 2
Bent 2 2
Energy Output To Patient Tissue Incorrect 2 2
Fracture 2 2
Difficult to Insert 2 2
Audible Prompt/Feedback Problem 2 2
Operating System Becomes Nonfunctional 2 2
Output Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Material Rupture 1 1
Loss of Power 1 1
Peeled/Delaminated 1 1
Device Expiration Issue 1 1
Computer Software Problem 1 1
Corroded 1 1
Degraded 1 1
Vibration 1 1
Device Dislodged or Dislocated 1 1
Improper Device Output 1 1
No Flow 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 512 512
No Known Impact Or Consequence To Patient 448 448
Complaint, Ill-Defined 245 245
Therapeutic Effects, Unexpected 210 210
Therapeutic Response, Decreased 194 194
Unspecified Infection 184 184
Neurological Deficit/Dysfunction 173 173
Insufficient Information 130 130
Pain 125 125
Electric Shock 96 96
Ambulation Difficulties 77 77
Dysphasia 71 71
Discomfort 60 60
Shaking/Tremors 52 52
Muscle Spasm(s) 45 45
Muscular Rigidity 40 40
Cognitive Changes 33 33
Intracranial Hemorrhage 32 32
Tingling 31 31
Burning Sensation 29 29
Undesired Nerve Stimulation 27 27
Bacterial Infection 27 27
Unspecified Nervous System Problem 27 27
Headache 26 26
Staphylococcus Aureus 26 26
Scar Tissue 25 25
Post Operative Wound Infection 24 24
Seizures 22 22
Seroma 21 21
Neck Stiffness 21 21
Dysphagia/ Odynophagia 20 20
Erythema 19 19
Twitching 19 19
Malaise 18 18
Erosion 18 18
Purulent Discharge 17 17
Dyskinesia 17 17
Swelling 17 17
Stroke/CVA 16 16
Convulsion/Seizure 16 16
Neck Pain 15 15
Fall 15 15
Fatigue 15 15
Pocket Erosion 15 15
Skin Erosion 14 14
Inflammation 14 14
Wound Dehiscence 14 14
Swelling/ Edema 14 14
Fluid Discharge 13 13
Test Result 12 12
Cramp(s) /Muscle Spasm(s) 12 12
Death 12 12
Edema 12 12
Fever 12 12
Paresis 12 12
Foreign Body Reaction 11 11
Hematoma 10 10
Hypersensitivity/Allergic reaction 10 10
Dizziness 10 10
No Code Available 10 10
Sleep Dysfunction 9 9
Depression 9 9
Anxiety 9 9
Distress 9 9
Impaired Healing 9 9
Memory Loss/Impairment 9 9
Emotional Changes 9 9
Hemorrhage/Bleeding 8 8
Hemorrhage, Cerebral 8 8
Visual Impairment 8 8
Respiratory Failure 8 8
Confusion/ Disorientation 8 8
Weight Changes 8 8
Tissue Breakdown 8 8
Loss of consciousness 7 7
Cramp(s) 7 7
Numbness 7 7
Pneumonia 7 7
Device Overstimulation of Tissue 7 7
Muscle Weakness 7 7
Adhesion(s) 7 7
Abscess 6 6
Cyst(s) 6 6
Irritation 6 6
Paralysis 6 6
Irritability 6 6
Device Embedded In Tissue or Plaque 5 5
Loss of Range of Motion 5 5
Nausea 5 5
Itching Sensation 4 4
Dyspnea 4 4
Cellulitis 4 4
Bruise/Contusion 4 4
Respiratory Distress 4 4
Tinnitus 4 4
Urinary Tract Infection 4 4
Injury 4 4
Visual Disturbances 4 4
Vomiting 4 4
Weakness 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II May-24-2022
2 Medtronic Neuromodulation I May-01-2013
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