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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 6

MDR Year MDR Reports MDR Events
2019 2549 2549
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1826 1826
2024 1045 1045

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3290 3290
Adverse Event Without Identified Device or Use Problem 2709 2709
Therapeutic or Diagnostic Output Failure 1857 1857
High impedance 1712 1712
Fracture 1196 1196
Insufficient Information 294 294
Material Fragmentation 262 262
Wireless Communication Problem 221 221
Use of Device Problem 214 214
Battery Problem 198 198
Impedance Problem 188 188
Disconnection 123 123
Patient-Device Incompatibility 111 111
Inappropriate/Inadequate Shock/Stimulation 103 103
Low impedance 74 74
Failure to Deliver Energy 68 68
Premature Elective Replacement Indicator 54 54
Break 46 46
No Apparent Adverse Event 39 39
Migration or Expulsion of Device 34 34
Therapy Delivered to Incorrect Body Area 31 31
Improper or Incorrect Procedure or Method 27 27
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
Temperature Problem 10 10
Premature Discharge of Battery 9 9
Pocket Stimulation 9 9
Difficult to Insert 9 9
Material Separation 8 8
Intermittent Energy Output 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
Device Damaged by Another Device 5 5
Incomplete or Inadequate Connection 4 4
Material Frayed 4 4
Energy Output Problem 3 3
Failure to Disconnect 3 3
High Readings 3 3
Communication or Transmission Problem 3 3
Positioning Problem 3 3
Naturally Worn 2 2
Appropriate Term/Code Not Available 2 2
Premature End-of-Life Indicator 2 2
Entrapment of Device 2 2
Fluid/Blood Leak 1 1
Corroded 1 1
Product Quality Problem 1 1
Output above Specifications 1 1
Loose or Intermittent Connection 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Charging Problem 1 1
Defibrillation/Stimulation Problem 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Loss of Data 1 1
Detachment of Device or Device Component 1 1
Device Misassembled During Manufacturing /Shipping 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 8586 8586
No Clinical Signs, Symptoms or Conditions 661 661
No Consequences Or Impact To Patient 516 516
Failure of Implant 490 490
Implant Pain 473 473
Pain 292 292
Undesired Nerve Stimulation 222 222
Cerebrospinal Fluid Leakage 208 208
Post Operative Wound Infection 190 190
Unspecified Infection 167 167
Discomfort 155 155
Insufficient Information 126 126
No Known Impact Or Consequence To Patient 92 92
Wound Dehiscence 84 84
Headache 83 83
Foreign Body In Patient 80 80
Fall 76 76
Erosion 74 74
Numbness 68 68
Device Embedded In Tissue or Plaque 63 63
Muscle Weakness 45 45
Headache, Lumbar Puncture 40 40
Hematoma 37 37
Device Overstimulation of Tissue 32 32
Fever 29 29
Scar Tissue 26 26
Burning Sensation 23 23
Vomiting 22 22
Fluid Discharge 22 22
Weakness 20 20
Cramp(s) /Muscle Spasm(s) 18 18
Twiddlers Syndrome 16 16
Nausea 16 16
Bacterial Infection 15 15
Hypersensitivity/Allergic reaction 14 14
Death 13 13
Muscle Spasm(s) 11 11
Skin Erosion 11 11
Seroma 10 10
Cramp(s) 10 10
Decreased Respiratory Rate 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
Swelling/ Edema 6 6
Dizziness 6 6
Coma 5 5
Skin Inflammation/ Irritation 5 5
Incontinence 5 5
Paralysis 5 5
Seizures 5 5
Abdominal Pain 5 5
Aspiration/Inhalation 5 5
Dyspnea 5 5
Apnea 4 4
Arrhythmia 4 4
Sepsis 4 4
Pocket Erosion 4 4
Shock 4 4
Respiratory Distress 4 4
Twitching 4 4
Respiratory Arrest 4 4
Ambulation Difficulties 4 4
Patient Problem/Medical Problem 3 3
Low Oxygen Saturation 3 3
Twiddlers Syndrome 3 3
Reaction to Medicinal Component of Device 3 3
Erectile Dysfunction 3 3
Rash 3 3
Neurological Deficit/Dysfunction 3 3
Pulmonary Embolism 3 3
Edema 3 3
Cyst(s) 3 3
Hemorrhage/Bleeding 3 3
Stroke/CVA 2 2
Air Embolism 2 2
Atrial Fibrillation 2 2
Myocardial Infarction 2 2
Erythema 2 2
Vertigo 2 2
Skin Irritation 2 2
Unspecified Tissue Injury 2 2
Embolism/Embolus 2 2
Blister 2 2
Balance Problems 2 2
Respiratory Failure 2 2
Paraplegia 2 2
Spinal Cord Injury 2 2
Neck Pain 2 2
Neck Stiffness 2 2
Shock from Patient Lead(s) 2 2
Reaction 2 2
Chills 2 2
Shock, Traumatic 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-16-2024
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