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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
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 130 130

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 407 407
High impedance 243 243
Battery Problem 224 224
Charging Problem 206 206
Connection Problem 201 201
Failure to Deliver Energy 183 183
Device Operates Differently Than Expected 180 180
Material Integrity Problem 168 168
Communication or Transmission Problem 120 120
Break 114 114
Low impedance 107 107
Insufficient Information 101 101
Migration or Expulsion of Device 91 91
Inappropriate/Inadequate Shock/Stimulation 88 88
Malposition of Device 71 71
Device Displays Incorrect Message 69 69
Impedance Problem 67 67
Improper or Incorrect Procedure or Method 66 66
Premature Discharge of Battery 53 53
Electromagnetic Compatibility Problem 51 51
Low Battery 46 46
Delayed Charge Time 45 45
Unintended Collision 44 44
Intermittent Continuity 39 39
Failure to Power Up 36 36
Energy Output Problem 33 33
Failure to Interrogate 33 33
Electromagnetic Interference 31 31
Overheating of Device 28 28
Patient Device Interaction Problem 27 27
Unstable 24 24
Display or Visual Feedback Problem 20 20
Therapeutic or Diagnostic Output Failure 18 18
Therapy Delivered to Incorrect Body Area 17 17
Material Frayed 17 17
Material Deformation 14 14
Data Problem 14 14
Positioning Problem 11 11
Loss of Data 11 11
Application Program Problem 10 10
Pocket Stimulation 10 10
No Device Output 10 10
Unexpected Therapeutic Results 8 8
Electro-Static Discharge 5 5
Unable to Obtain Readings 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Use of Device Problem 4 4
Device Or Device Fragments Location Unknown 4 4
Environmental Compatibility Problem 4 4
Material Twisted/Bent 4 4
Power Problem 4 4
Unauthorized Access to Computer System 3 3
Unintended Movement 3 3
Noise, Audible 3 3
Device Contamination with Chemical or Other Material 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged by Another Device 3 3
Difficult to Remove 3 3
Device Difficult to Program or Calibrate 3 3
Nonstandard Device 3 3
Disconnection 3 3
Use of Incorrect Control/Treatment Settings 3 3
Bent 2 2
Fracture 2 2
Difficult to Insert 2 2
Shelf Life Exceeded 2 2
Shipping Damage or Problem 2 2
Operating System Becomes Nonfunctional 2 2
Inadequacy of Device Shape and/or Size 2 2
Audible Prompt/Feedback Problem 2 2
Appropriate Term/Code Not Available 1 1
Vibration 1 1
Output Problem 1 1
No Flow 1 1
Improper Device Output 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Material Rupture 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1
Device Expiration Issue 1 1
Computer Software Problem 1 1
Corroded 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 505 505
No Known Impact Or Consequence To Patient 376 376
Complaint, Ill-Defined 188 188
Therapeutic Effects, Unexpected 170 170
Unspecified Infection 159 159
Therapeutic Response, Decreased 156 156
Neurological Deficit/Dysfunction 137 137
Insufficient Information 130 130
Pain 107 107
Electric Shock 86 86
Ambulation Difficulties 65 65
Dysphasia 64 64
Discomfort 50 50
Shaking/Tremors 46 46
Muscle Spasm(s) 34 34
Muscular Rigidity 32 32
Intracranial Hemorrhage 32 32
Cognitive Changes 30 30
Burning Sensation 28 28
Unspecified Nervous System Problem 27 27
Headache 22 22
Bacterial Infection 21 21
Scar Tissue 20 20
Tingling 20 20
Post Operative Wound Infection 20 20
Neck Stiffness 19 19
Staphylococcus Aureus 19 19
Seizures 18 18
Erosion 18 18
Dysphagia/ Odynophagia 18 18
Erythema 18 18
Undesired Nerve Stimulation 17 17
Malaise 17 17
Twitching 16 16
Swelling 16 16
Convulsion/Seizure 16 16
Seroma 15 15
Fall 15 15
Fatigue 15 15
Stroke/CVA 15 15
Purulent Discharge 14 14
Dyskinesia 14 14
Swelling/ Edema 14 14
Pocket Erosion 13 13
Wound Dehiscence 12 12
Cramp(s) /Muscle Spasm(s) 12 12
Inflammation 11 11
Skin Erosion 11 11
Neck Pain 11 11
Dizziness 10 10
Paresis 10 10
Hypersensitivity/Allergic reaction 10 10
Death 10 10
Fever 10 10
Edema 10 10
Fluid Discharge 10 10
Emotional Changes 9 9
Memory Loss/Impairment 9 9
Hematoma 8 8
Visual Impairment 8 8
Anxiety 8 8
Impaired Healing 8 8
Weight Changes 8 8
Test Result 8 8
No Code Available 8 8
Confusion/ Disorientation 8 8
Sleep Dysfunction 8 8
Depression 7 7
Foreign Body Reaction 7 7
Muscle Weakness 7 7
Adhesion(s) 7 7
Abscess 6 6
Hemorrhage, Cerebral 6 6
Cramp(s) 6 6
Numbness 5 5
Irritability 5 5
Pneumonia 5 5
Hemorrhage/Bleeding 5 5
Irritation 5 5
Nausea 5 5
Tissue Breakdown 5 5
Respiratory Failure 4 4
Post Traumatic Wound Infection 4 4
Cellulitis 4 4
Bruise/Contusion 4 4
Dyspnea 4 4
Cyst(s) 4 4
Loss of Range of Motion 4 4
Visual Disturbances 4 4
Vomiting 4 4
Weakness 4 4
Urinary Tract Infection 4 4
Loss of consciousness 4 4
Injury 4 4
Distress 4 4
Seizures, Grand-Mal 3 3
Sepsis 3 3
Tinnitus 3 3
Seizures, Focal Motor 3 3
Paralysis 3 3

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