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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)
2020 2021 2022 2023 2024 2025
8 13 3 9 13 10

MDR Year MDR Reports MDR Events
2020 2323 2323
2021 2304 2307
2022 1956 1958
2023 1824 1827
2024 2075 2075
2025 1843 1843

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3892 3896
Therapeutic or Diagnostic Output Failure 1905 1905
High impedance 1853 1853
Adverse Event Without Identified Device or Use Problem 1756 1757
Fracture 1359 1359
Use of Device Problem 347 347
Insufficient Information 324 324
Material Fragmentation 323 323
Wireless Communication Problem 259 261
Battery Problem 246 246
Impedance Problem 192 192
Inappropriate/Inadequate Shock/Stimulation 120 120
Low impedance 93 93
Patient-Device Incompatibility 83 83
Disconnection 80 80
Failure to Deliver Energy 71 71
No Apparent Adverse Event 66 66
Break 50 51
Improper or Incorrect Procedure or Method 38 38
Therapy Delivered to Incorrect Body Area 30 30
Separation Failure 30 30
Material Twisted/Bent 27 27
Premature Elective Replacement Indicator 18 18
Temperature Problem 17 17
Material Split, Cut or Torn 17 17
Pocket Stimulation 17 17
Migration or Expulsion of Device 16 16
Failure to Advance 15 15
Difficult to Remove 14 14
Mechanical Jam 12 12
Unexpected Shutdown 11 11
Difficult to Insert 9 9
Intermittent Energy Output 7 7
Material Separation 4 4
Incomplete or Inadequate Connection 4 4
Device Damaged by Another Device 3 3
Energy Output Problem 3 3
Premature Discharge of Battery 3 3
Failure to Disconnect 3 3
Material Protrusion/Extrusion 2 2
Positioning Problem 2 2
Naturally Worn 2 2
Entrapment of Device 2 2
Material Frayed 2 2
Material Discolored 1 1
Charging Problem 1 1
Device Handling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Patient Device Interaction Problem 1 1
Output above Specifications 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 8801 8807
Failure of Implant 1114 1115
No Clinical Signs, Symptoms or Conditions 901 902
Implant Pain 655 656
Undesired Nerve Stimulation 277 277
No Consequences Or Impact To Patient 253 253
Post Operative Wound Infection 223 223
Foreign Body In Patient 215 215
Insufficient Information 177 177
Pain 176 176
Cerebrospinal Fluid Leakage 160 160
Unspecified Infection 157 157
Device Embedded In Tissue or Plaque 136 136
Wound Dehiscence 93 93
Headache 78 78
Discomfort 75 75
Erosion 69 69
No Known Impact Or Consequence To Patient 58 58
Numbness 51 51
Muscle Weakness 37 37
Fluid Discharge 36 36
Burning Sensation 32 32
Cramp(s) /Muscle Spasm(s) 30 30
Scar Tissue 28 28
Skin Erosion 27 27
Hematoma 22 22
Vomiting 19 19
Fever 18 18
Hypersensitivity/Allergic reaction 16 16
Bacterial Infection 14 14
Twiddlers Syndrome 13 13
Fall 13 13
Swelling/ Edema 13 13
Movement Disorder 12 12
Headache, Lumbar Puncture 11 11
Decreased Respiratory Rate 11 11
Nausea 11 11
Cardiac Arrest 11 11
Seroma 10 10
Purulent Discharge 8 8
Hemorrhage/Bleeding 8 8
No Information 7 7
Convulsion/Seizure 7 7
Device Overstimulation of Tissue 7 7
Skin Inflammation/ Irritation 6 6
Respiratory Arrest 6 6
Death 6 6
Swelling 5 5
Sepsis 5 5
Incontinence 5 5

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