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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 206 206

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 476 476
High impedance 298 298
Battery Problem 248 248
Device Operates Differently Than Expected 233 233
Charging Problem 232 232
Failure to Deliver Energy 217 217
Connection Problem 215 215
Material Integrity Problem 180 180
Communication or Transmission Problem 153 153
Break 135 135
Low impedance 128 128
Migration or Expulsion of Device 107 107
Insufficient Information 107 107
Inappropriate/Inadequate Shock/Stimulation 100 100
Device Displays Incorrect Message 87 87
Malposition of Device 87 87
Improper or Incorrect Procedure or Method 78 78
Impedance Problem 74 74
Low Battery 71 71
Electromagnetic Compatibility Problem 68 68
Premature Discharge of Battery 60 60
Delayed Charge Time 53 53
Unintended Collision 50 50
Intermittent Continuity 49 49
Failure to Interrogate 42 42
Failure to Power Up 39 39
Electromagnetic Interference 38 38
Energy Output Problem 35 35
Overheating of Device 33 33
Patient Device Interaction Problem 30 30
Unstable 29 29
Display or Visual Feedback Problem 22 22
Therapy Delivered to Incorrect Body Area 19 19
Material Deformation 18 18
Therapeutic or Diagnostic Output Failure 18 18
Material Frayed 18 18
Pocket Stimulation 17 17
Data Problem 14 14
Positioning Problem 14 14
Loss of Data 11 11
No Device Output 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
Device Contamination with Chemical or Other Material 5 5
Electro-Static Discharge 5 5
Use of Device Problem 4 4
Material Twisted/Bent 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 551 551
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 191 191
Neurological Deficit/Dysfunction 173 173
Insufficient Information 142 142
Pain 126 126
Electric Shock 97 97
Ambulation Difficulties 81 81
Dysphasia 74 74
Discomfort 62 62
Shaking/Tremors 55 55
Muscle Spasm(s) 45 45
Muscular Rigidity 42 42
Cognitive Changes 34 34
Intracranial Hemorrhage 32 32
Tingling 31 31
Burning Sensation 31 31
Unspecified Nervous System Problem 30 30
Undesired Nerve Stimulation 27 27
Headache 27 27
Bacterial Infection 27 27
Scar Tissue 26 26
Staphylococcus Aureus 26 26
Post Operative Wound Infection 24 24
Seizures 22 22
Seroma 21 21
Neck Stiffness 21 21
Erosion 21 21
Twitching 20 20
Dysphagia/ Odynophagia 20 20
Erythema 19 19
Malaise 18 18
Dyskinesia 17 17
Purulent Discharge 17 17
Swelling 17 17
Convulsion/Seizure 16 16
Fall 16 16
Pocket Erosion 16 16
Fluid Discharge 16 16
Stroke/CVA 16 16
Fatigue 15 15
Neck Pain 15 15
Skin Erosion 14 14
Inflammation 14 14
Swelling/ Edema 14 14
Wound Dehiscence 14 14
Test Result 12 12

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