Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
18 28 31 25 23 25 18 37 45 36 42 37 36 34 31 10

MDR Year MDR Reports MDR Events
2014 2621 2621
2015 3088 3088
2016 3558 3558
2017 3560 3560
2018 4494 4494
2019 2818 2818
2020 2674 2674
2021 2426 2426
2022 2257 2257
2023 3495 3495
2024 1802 1802

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7909 7909
High impedance 4502 4502
Device Operates Differently Than Expected 3517 3517
Battery Problem 2671 2671
Failure to Deliver Energy 2353 2353
Connection Problem 2113 2113
Charging Problem 1958 1958
Low impedance 1845 1845
Break 1734 1734
Material Integrity Problem 1714 1714
Insufficient Information 1564 1564
Inappropriate/Inadequate Shock/Stimulation 1473 1473
Communication or Transmission Problem 1456 1456
Device Displays Incorrect Message 1232 1232
Unintended Collision 974 974
Electromagnetic Compatibility Problem 970 970
Premature Discharge of Battery 968 968
Migration or Expulsion of Device 875 875
Component Misassembled 828 828
Malposition of Device 762 762
Low Battery 748 748
Impedance Problem 711 711
Energy Output Problem 640 640
Failure to Interrogate 595 595
Failure to Power Up 571 571
Delayed Charge Time 509 509
Intermittent Continuity 489 489
Improper or Incorrect Procedure or Method 441 441
Therapy Delivered to Incorrect Body Area 421 421
Electromagnetic Interference 420 420
Therapeutic or Diagnostic Output Failure 405 405
Material Deformation 388 388
Unstable 381 381
Shipping Damage or Problem 300 300
Display or Visual Feedback Problem 279 279
Overheating of Device 247 247
Material Twisted/Bent 193 193
Patient Device Interaction Problem 193 193
No Device Output 174 174
Pocket Stimulation 165 165
Fracture 163 163
Material Frayed 154 154
Positioning Problem 151 151
Data Problem 147 147
Loss of Data 145 145
Premature Elective Replacement Indicator 144 144
Wireless Communication Problem 141 141
Device Contamination with Chemical or Other Material 131 131
Device Or Device Fragments Location Unknown 126 126
Migration 125 125
Unexpected Therapeutic Results 118 118
Use of Device Problem 110 110
Disconnection 100 100
Bent 97 97
Difficult to Open or Close 94 94
Human-Device Interface Problem 83 83
Appropriate Term/Code Not Available 80 80
Incorrect, Inadequate or Imprecise Result or Readings 75 75
Environmental Compatibility Problem 64 64
Activation, Positioning or Separation Problem 64 64
Application Program Problem 61 61
Inadequacy of Device Shape and/or Size 52 52
Difficult to Remove 51 51
Device Difficult to Program or Calibrate 50 50
No Apparent Adverse Event 50 50
Energy Output To Patient Tissue Incorrect 49 49
Component Missing 47 47
Improper Device Output 44 44
Device Damaged by Another Device 41 41
Difficult to Insert 41 41
Unable to Obtain Readings 41 41
Operating System Becomes Nonfunctional 41 41
Shelf Life Exceeded 39 39
Device Markings/Labelling Problem 36 36
Noise, Audible 33 33
Vibration 29 29
Electro-Static Discharge 25 25
Mechanical Problem 25 25
Peeled/Delaminated 23 23
Degraded 21 21
Defective Device 21 21
Unintended Movement 21 21
Ambient Noise Problem 20 20
Failure to Advance 16 16
Use of Incorrect Control/Treatment Settings 16 16
Patient-Device Incompatibility 15 15
Stretched 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Contamination 13 13
Labelling, Instructions for Use or Training Problem 12 12
Device Inoperable 12 12
Unsealed Device Packaging 11 11
Loss of Power 10 10
Device Contaminated During Manufacture or Shipping 10 10
Nonstandard Device 9 9
Material Fragmentation 9 9
Audible Prompt/Feedback Problem 9 9
Application Program Freezes, Becomes Nonfunctional 8 8
Temperature Problem 8 8
Corroded 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7693 7693
No Clinical Signs, Symptoms or Conditions 6111 6111
Unspecified Infection 2857 2858
Complaint, Ill-Defined 2697 2697
Shaking/Tremors 2565 2567
Therapeutic Effects, Unexpected 2508 2508
Therapeutic Response, Decreased 2331 2331
Ambulation Difficulties 1505 1505
Electric Shock 1425 1425
Inadequate Pain Relief 1155 1155
No Consequences Or Impact To Patient 993 993
Pain 979 980
Insufficient Information 972 972
Cognitive Changes 910 911
Dysphasia 871 872
Fall 694 694
Muscular Rigidity 684 685
Discomfort 605 605
Erosion 596 596
Undesired Nerve Stimulation 511 511
Tingling 492 492
Neurological Deficit/Dysfunction 430 431
Dyskinesia 413 413
Stroke/CVA 411 411
Post Operative Wound Infection 410 410
Seizures 389 389
Intracranial Hemorrhage 371 371
Erythema 352 352
No Code Available 349 350
Bacterial Infection 311 311
Headache 306 306
Purulent Discharge 303 303
Skin Erosion 303 303
Wound Dehiscence 299 299
Burning Sensation 298 298
Swelling 290 290
Staphylococcus Aureus 278 278
Pocket Erosion 248 248
Confusion/ Disorientation 245 245
Hematoma 239 239
Failure of Implant 233 233
Device Overstimulation of Tissue 217 217
Fluid Discharge 208 208
Anxiety 207 207
Dizziness 190 190
Sleep Dysfunction 188 188
Muscle Weakness 182 182
Movement Disorder 179 179
Death 178 178
Scar Tissue 177 177
Muscle Spasm(s) 176 176
Numbness 174 175
Loss of consciousness 172 172
Fatigue 172 172
Depression 166 166
Malaise 163 163
Dysphagia/ Odynophagia 157 157
Weakness 155 155
Impaired Healing 153 153
Hemorrhage/Bleeding 151 151
Emotional Changes 149 149
Edema 148 148
Swelling/ Edema 148 148
Inflammation 131 131
Hemorrhage, Cerebral 127 127
Injury 123 123
Irritability 116 116
Test Result 116 117
Convulsion/Seizure 107 107
Memory Loss/Impairment 107 107
Foreign Body Reaction 103 103
Bone Fracture(s) 102 102
Neck Stiffness 102 102
Paresthesia 102 102
Paresis 101 101
Twitching 98 98
Seroma 96 96
Fever 92 92
Visual Impairment 91 91
Dementia 89 89
Abscess 81 81
Weight Changes 78 78
Lethargy 77 77
Nausea 71 71
Neck Pain 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 69 69
Paralysis 63 63
Irritation 63 63
Adhesion(s) 63 63
Visual Disturbances 60 60
Dyspnea 59 59
Hypersensitivity/Allergic reaction 59 59
Unspecified Nervous System Problem 59 59
Distress 58 58
Implant Pain 56 56
Cramp(s) /Muscle Spasm(s) 55 55
Alteration In Body Temperature 55 55
Transient Ischemic Attack 55 55
High Blood Pressure/ Hypertension 54 54
Bruise/Contusion 54 54

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Neuromodulation Systems Inc. II Feb-28-2013
2 Medtronic Neuromodulation II Nov-03-2023
3 Medtronic Neuromodulation II Oct-18-2023
4 Medtronic Neuromodulation II Apr-19-2023
5 Medtronic Neuromodulation II May-24-2022
6 Medtronic Neuromodulation II Dec-27-2021
7 Medtronic Neuromodulation II Nov-24-2021
8 Medtronic Neuromodulation II Nov-04-2021
9 Medtronic Neuromodulation II Apr-07-2021
10 Medtronic Neuromodulation II Dec-16-2020
11 Medtronic Neuromodulation II Aug-23-2017
12 Medtronic Neuromodulation II Dec-03-2016
13 Medtronic Neuromodulation II Aug-24-2016
14 Medtronic Neuromodulation II Aug-19-2016
15 Medtronic Neuromodulation II May-15-2015
16 Medtronic Neuromodulation II Aug-18-2014
17 Medtronic Neuromodulation II Apr-29-2014
18 Medtronic Neuromodulation II Nov-14-2013
19 Medtronic Neuromodulation I May-01-2013
20 Medtronic Neuromodulation II Dec-19-2012
21 St. Jude Medical, Inc. II Dec-10-2018
22 St. Jude Medical, Inc. II Oct-17-2017
23 St. Jude Medical, Inc. II Jul-07-2017
-
-