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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dorsal root ganglion stimulator for pain relief
Definition Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.
Product CodePMP
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
5 8 13 3 9 3

MDR Year MDR Reports MDR Events
2019 2548 2548
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1826 1826
2024 569 569

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3162 3162
Adverse Event Without Identified Device or Use Problem 2631 2631
Therapeutic or Diagnostic Output Failure 1800 1800
High impedance 1617 1617
Fracture 1140 1140
Insufficient Information 287 287
Material Fragmentation 250 250
Wireless Communication Problem 211 211
Use of Device Problem 192 192
Battery Problem 187 187
Impedance Problem 179 179
Disconnection 122 122
Patient-Device Incompatibility 109 109
Inappropriate/Inadequate Shock/Stimulation 96 96
Low impedance 71 71
Failure to Deliver Energy 66 66
Premature Elective Replacement Indicator 54 54
Break 45 45
Migration or Expulsion of Device 34 34
No Apparent Adverse Event 34 34
Therapy Delivered to Incorrect Body Area 27 27
Improper or Incorrect Procedure or Method 26 26
No Device Output 23 23
Separation Failure 22 22
Material Twisted/Bent 20 20
Material Split, Cut or Torn 19 19
Unexpected Shutdown 14 14
Difficult to Remove 14 14
Mechanical Jam 12 12
Failure to Advance 11 11
Premature Discharge of Battery 9 9
Temperature Problem 9 9
Intermittent Energy Output 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
Material Separation 7 7
Pocket Stimulation 7 7
Difficult to Insert 6 6
Device Damaged by Another Device 5 5
Incomplete or Inadequate Connection 4 4
Material Frayed 4 4
Energy Output Problem 3 3
High Readings 3 3
Failure to Disconnect 3 3
Communication or Transmission Problem 3 3
Positioning Problem 3 3
Appropriate Term/Code Not Available 2 2
Premature End-of-Life Indicator 2 2
Entrapment of Device 2 2
Corroded 1 1
Loose or Intermittent Connection 1 1
Output above Specifications 1 1
Defibrillation/Stimulation Problem 1 1
Loss of Data 1 1
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Application Program Problem 1 1
Product Quality Problem 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Naturally Worn 1 1
Material Protrusion/Extrusion 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 8259 8259
No Clinical Signs, Symptoms or Conditions 621 621
No Consequences Or Impact To Patient 516 516
Implant Pain 432 432
Failure of Implant 325 325
Pain 290 290
Undesired Nerve Stimulation 205 205
Cerebrospinal Fluid Leakage 204 204
Post Operative Wound Infection 174 174
Unspecified Infection 159 159
Discomfort 154 154
Insufficient Information 117 117
No Known Impact Or Consequence To Patient 92 92
Wound Dehiscence 84 84
Headache 80 80
Fall 76 76
Numbness 67 67
Erosion 64 64
Foreign Body In Patient 63 63
Device Embedded In Tissue or Plaque 57 57
Muscle Weakness 44 44
Headache, Lumbar Puncture 40 40
Hematoma 37 37
Device Overstimulation of Tissue 32 32
Scar Tissue 24 24
Fever 24 24
Vomiting 22 22
Burning Sensation 21 21
Fluid Discharge 21 21
Weakness 20 20
Twiddlers Syndrome 16 16
Nausea 15 15
Bacterial Infection 15 15
Death 13 13
Cramp(s) /Muscle Spasm(s) 13 13
Hypersensitivity/Allergic reaction 12 12
Muscle Spasm(s) 11 11
Skin Erosion 11 11
Seroma 10 10
Decreased Respiratory Rate 10 10
Cramp(s) 10 10
Weight Changes 9 9
Purulent Discharge 9 9
Cardiac Arrest 8 8
Swelling 8 8
Therapeutic Effects, Unexpected 8 8
Impaired Healing 8 8
Movement Disorder 8 8
No Information 7 7
Convulsion/Seizure 6 6
Dizziness 6 6
Coma 5 5
Skin Inflammation/ Irritation 5 5
Swelling/ Edema 5 5
Seizures 5 5
Abdominal Pain 5 5
Aspiration/Inhalation 5 5
Dyspnea 5 5
Apnea 4 4
Arrhythmia 4 4
Respiratory Distress 4 4
Paralysis 4 4
Incontinence 4 4
Shock 4 4
Twitching 4 4
Respiratory Arrest 4 4
Ambulation Difficulties 4 4
Low Oxygen Saturation 3 3
Patient Problem/Medical Problem 3 3
Twiddlers Syndrome 3 3
Reaction to Medicinal Component of Device 3 3
Erectile Dysfunction 3 3
Neurological Deficit/Dysfunction 3 3
Pocket Erosion 3 3
Rash 3 3
Pulmonary Embolism 3 3
Edema 3 3
Cyst(s) 3 3
Hemorrhage/Bleeding 3 3
Erythema 2 2
Air Embolism 2 2
Atrial Fibrillation 2 2
Stroke/CVA 2 2
Sepsis 2 2
Myocardial Infarction 2 2
Chills 2 2
Skin Irritation 2 2
Embolism/Embolus 2 2
Blister 2 2
Unspecified Tissue Injury 2 2
Balance Problems 2 2
Shock from Patient Lead(s) 2 2
Reaction 2 2
Respiratory Failure 2 2
Paraplegia 2 2
Spinal Cord Injury 2 2
Neck Pain 2 2
Neck Stiffness 2 2
Vertigo 2 2
Shock, Traumatic 2 2

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