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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
42 37 36 34 31 21

MDR Year MDR Reports MDR Events
2019 2818 2818
2020 2674 2674
2021 2426 2426
2022 2258 2258
2023 3495 3495
2024 2663 2663

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3771 3771
High impedance 2239 2239
Connection Problem 1984 1984
Battery Problem 1811 1811
Material Integrity Problem 1698 1698
Insufficient Information 1355 1355
Charging Problem 1221 1221
Failure to Deliver Energy 1075 1075
Low impedance 795 795
Communication or Transmission Problem 770 770
Break 690 690
Failure to Power Up 616 616
Inappropriate/Inadequate Shock/Stimulation 583 583
Energy Output Problem 462 462
Impedance Problem 410 410
Therapeutic or Diagnostic Output Failure 381 381
Migration or Expulsion of Device 354 354
Electromagnetic Compatibility Problem 349 349
Failure to Interrogate 338 338
Malposition of Device 323 323
Premature Discharge of Battery 322 322
Improper or Incorrect Procedure or Method 312 312
Unintended Collision 303 303
Delayed Charge Time 257 257
Unstable 195 195
Display or Visual Feedback Problem 191 191
Material Deformation 172 172
Material Twisted/Bent 172 172
Patient Device Interaction Problem 168 168
Material Frayed 154 154
Wireless Communication Problem 148 148
Fracture 144 144
Electromagnetic Interference 142 142
Overheating of Device 140 140
Migration 135 135
Data Problem 128 128
Shipping Damage or Problem 123 123
Therapy Delivered to Incorrect Body Area 121 121
Intermittent Continuity 116 116
Loss of Data 101 101
Use of Device Problem 82 82
Positioning Problem 81 81
Unexpected Therapeutic Results 74 74
Difficult to Open or Close 71 71
Application Program Problem 61 61
No Device Output 61 61
No Apparent Adverse Event 54 54
Operating System Becomes Nonfunctional 46 46
Disconnection 45 45
Pocket Stimulation 44 44
Device Contamination with Chemical or Other Material 40 40
Unintended Application Program Shut Down 37 37
Activation, Positioning or Separation Problem 35 35
Difficult to Remove 35 35
Human-Device Interface Problem 34 34
Premature Elective Replacement Indicator 30 30
Difficult to Insert 28 28
Component Missing 27 27
Device Markings/Labelling Problem 27 27
Noise, Audible 24 24
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Device Difficult to Program or Calibrate 22 22
Mechanical Problem 21 21
Unintended Movement 21 21
Vibration 19 19
Failure to Advance 16 16
Unable to Obtain Readings 16 16
Defective Device 15 15
Appropriate Term/Code Not Available 15 15
Environmental Compatibility Problem 14 14
Inadequacy of Device Shape and/or Size 13 13
Degraded 13 13
Audible Prompt/Feedback Problem 12 12
Unexpected Shutdown 11 11
Contamination 11 11
Electro-Static Discharge 11 11
Delayed Alarm 10 10
Corroded 9 9
Device Damaged by Another Device 9 9
Material Fragmentation 8 8
Peeled/Delaminated 8 8
Unsealed Device Packaging 7 7
Intermittent Energy Output 7 7
Temperature Problem 6 6
Device Displays Incorrect Message 6 6
Ambient Noise Problem 6 6
Use of Incorrect Control/Treatment Settings 5 5
Unauthorized Access to Computer System 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Application Program Freezes, Becomes Nonfunctional 5 5
Mechanical Jam 4 4
Power Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Failure to Charge 4 4
Failure to Disconnect 3 3
Stretched 3 3
Component Misassembled 3 3
Material Split, Cut or Torn 3 3
Compatibility Problem 2 2
Off-Label Use 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6583 6583
No Known Impact Or Consequence To Patient 1927 1927
Unspecified Infection 1392 1392
Inadequate Pain Relief 1032 1032
Insufficient Information 1031 1031
Shaking/Tremors 944 944
Electric Shock 566 566
Ambulation Difficulties 505 505
Complaint, Ill-Defined 459 459
Erosion 414 414
Therapeutic Response, Decreased 407 407
Failure of Implant 361 361
Movement Disorder 344 344
Pain 337 337
Therapeutic Effects, Unexpected 311 311
Cognitive Changes 292 292
Dysphasia 290 290
Fall 254 254
Discomfort 239 239
Post Operative Wound Infection 218 218
Intracranial Hemorrhage 215 215
Muscular Rigidity 211 211
No Code Available 192 192
Wound Dehiscence 168 168
Swelling/ Edema 160 160
Undesired Nerve Stimulation 141 141
Bacterial Infection 137 137
Stroke/CVA 134 134
No Consequences Or Impact To Patient 131 131
Headache 129 129
Burning Sensation 127 127
Purulent Discharge 116 116
Dyskinesia 116 116
Erythema 114 114
Convulsion/Seizure 113 113
Paresthesia 109 109
Pocket Erosion 106 106
Hematoma 103 103
Confusion/ Disorientation 92 92
Tingling 92 92
Fluid Discharge 84 84
Device Overstimulation of Tissue 83 83
Muscle Weakness 79 79
Skin Erosion 79 79
Scar Tissue 75 75
Loss of consciousness 72 72
Impaired Healing 71 71
Implant Pain 71 71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 70 70
Seizures 69 69
Numbness 67 67
Hemorrhage/Bleeding 63 63
Sleep Dysfunction 60 60
Unspecified Nervous System Problem 59 59
Fatigue 59 59
Cramp(s) /Muscle Spasm(s) 57 57
Inflammation 56 56
Swelling 55 55
Dizziness 53 53
Neurological Deficit/Dysfunction 52 52
Depression 50 50
Dysphagia/ Odynophagia 48 48
Emotional Changes 47 47
Twiddlers Syndrome 47 47
Anxiety 42 42
Malaise 42 42
Bone Fracture(s) 38 38
Weight Changes 36 36
Neck Stiffness 35 35
Fever 34 34
Visual Impairment 34 34
Paresis 33 33
Memory Loss/Impairment 33 33
Twitching 33 33
Hypersensitivity/Allergic reaction 31 31
Edema 31 31
Paralysis 30 30
Nausea 30 30
Foreign Body Reaction 29 29
Adhesion(s) 29 29
Seroma 28 28
Twiddlers Syndrome 27 27
Abscess 27 27
Dyspnea 27 27
Death 27 27
Weakness 27 27
Irritability 26 26
Lethargy 26 26
Suicidal Ideation 26 26
Staphylococcus Aureus 26 26
Muscle Spasm(s) 26 26
Hallucination 25 25
Neck Pain 25 25
Hemorrhage, Cerebral 24 24
Unspecified Tissue Injury 23 23
High Blood Pressure/ Hypertension 20 20
Visual Disturbances 19 19
Skin Inflammation/ Irritation 19 19
Device Embedded In Tissue or Plaque 19 19
Speech Disorder 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-03-2024
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
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