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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 2

MDR Year MDR Reports MDR Events
2019 2548 2548
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1824 1824
2024 170 170

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3040 3040
Adverse Event Without Identified Device or Use Problem 2569 2569
Therapeutic or Diagnostic Output Failure 1753 1753
High impedance 1530 1530
Fracture 1103 1103
Insufficient Information 282 282
Material Fragmentation 241 241
Wireless Communication Problem 204 204
Battery Problem 182 182
Impedance Problem 175 175
Use of Device Problem 169 169
Disconnection 117 117
Patient-Device Incompatibility 103 103
Inappropriate/Inadequate Shock/Stimulation 93 93
Low impedance 67 67
Failure to Deliver Energy 66 66
Premature Elective Replacement Indicator 54 54
Break 43 43
Migration or Expulsion of Device 34 34
No Apparent Adverse Event 33 33
Therapy Delivered to Incorrect Body Area 27 27
Improper or Incorrect Procedure or Method 25 25
No Device Output 23 23
Separation Failure 21 21
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
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
Incomplete or Inadequate Connection 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
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Application Program Problem 1 1
Product Quality Problem 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Naturally Worn 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 7981 7981
No Clinical Signs, Symptoms or Conditions 589 589
No Consequences Or Impact To Patient 516 516
Implant Pain 389 389
Pain 288 288
Failure of Implant 247 247
Cerebrospinal Fluid Leakage 198 198
Undesired Nerve Stimulation 189 189
Post Operative Wound Infection 171 171
Unspecified Infection 157 157
Discomfort 154 154
Insufficient Information 112 112
No Known Impact Or Consequence To Patient 92 92
Wound Dehiscence 82 82
Headache 77 77
Fall 76 76
Numbness 66 66
Erosion 64 64
Device Embedded In Tissue or Plaque 51 51
Foreign Body In Patient 47 47
Muscle Weakness 41 41
Headache, Lumbar Puncture 40 40
Hematoma 37 37
Device Overstimulation of Tissue 32 32
Fever 24 24
Vomiting 22 22
Burning Sensation 21 21
Weakness 20 20
Scar Tissue 19 19
Fluid Discharge 19 19
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
Seroma 10 10
Skin Erosion 10 10
Cramp(s) 10 10
Decreased Respiratory Rate 10 10
Purulent Discharge 9 9
Cardiac Arrest 8 8
Swelling 8 8
Therapeutic Effects, Unexpected 8 8
Weight Changes 8 8
Impaired Healing 8 8
No Information 7 7
Movement Disorder 7 7
Convulsion/Seizure 6 6
Dizziness 6 6
Seizures 5 5
Dyspnea 5 5
Abdominal Pain 5 5
Aspiration/Inhalation 5 5
Skin Inflammation/ Irritation 5 5
Coma 5 5
Ambulation Difficulties 4 4
Swelling/ Edema 4 4
Respiratory Arrest 4 4
Apnea 4 4
Arrhythmia 4 4
Incontinence 4 4
Shock 4 4
Respiratory Distress 4 4
Paralysis 4 4
Twitching 4 4
Neurological Deficit/Dysfunction 3 3
Pocket Erosion 3 3
Rash 3 3
Hemorrhage/Bleeding 3 3
Cyst(s) 3 3
Pulmonary Embolism 3 3
Edema 3 3
Erectile Dysfunction 3 3
Reaction to Medicinal Component of Device 3 3
Low Oxygen Saturation 3 3
Patient Problem/Medical Problem 3 3
Reaction 2 2
Balance Problems 2 2
Shock from Patient Lead(s) 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
Twiddlers Syndrome 2 2
Unspecified Tissue Injury 2 2
Blister 2 2
Embolism/Embolus 2 2
Stroke/CVA 2 2
Air Embolism 2 2
Atrial Fibrillation 2 2
Erythema 2 2
Sepsis 2 2
Myocardial Infarction 2 2
Chills 2 2
Skin Irritation 2 2

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