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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)
2021 2022 2023 2024 2025 2026
13 3 9 13 11 3

MDR Year MDR Reports MDR Events
2021 2304 2307
2022 1958 1960
2023 1825 1828
2024 2074 2074
2025 1985 1985
2026 806 806

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3533 3537
High impedance 1663 1663
Adverse Event Without Identified Device or Use Problem 1495 1496
Therapeutic or Diagnostic Output Failure 1478 1478
Fracture 1257 1257
Use of Device Problem 356 356
Material Fragmentation 289 289
Insufficient Information 257 257
Battery Problem 241 241
Wireless Communication Problem 226 228
Impedance Problem 169 169
Inappropriate/Inadequate Shock/Stimulation 100 100
Low impedance 85 85
No Apparent Adverse Event 71 71
Patient-Device Incompatibility 57 57
Disconnection 54 54
Failure to Deliver Energy 49 49
Break 47 48
Improper or Incorrect Procedure or Method 30 30
Separation Failure 29 29
Therapy Delivered to Incorrect Body Area 28 28
Material Twisted/Bent 20 20
Premature Discharge of Battery 18 18
Temperature Problem 17 17
Pocket Stimulation 16 16
Failure to Advance 14 14
Mechanical Jam 12 12
Difficult to Remove 11 11
Migration or Expulsion of Device 8 8
Unexpected Shutdown 8 8
Difficult to Insert 7 7
Material Separation 7 7
Material Split, Cut or Torn 7 7
Intermittent Energy Output 6 6
Electromagnetic Compatibility Problem 5 5
Malposition of Device 4 4
Premature Elective Replacement Indicator 4 4
Entrapment of Device 4 4
Failure to Disconnect 3 3
Energy Output Problem 2 2
Incomplete or Inadequate Connection 2 2
Naturally Worn 2 2
Corroded 1 1
Loss of Data 1 1
Fluid/Blood Leak 1 1
Material Protrusion/Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 7787 7793
Failure of Implant 1100 1101
No Clinical Signs, Symptoms or Conditions 984 985
Implant Pain 710 711
Undesired Nerve Stimulation 261 261
Foreign Body In Patient 236 236
Insufficient Information 223 223
Post Operative Wound Infection 209 209
Device Embedded In Tissue or Plaque 162 162
Unspecified Infection 144 144
Cerebrospinal Fluid Leakage 111 111
Pain 77 77
Wound Dehiscence 75 75
Headache 69 69
Erosion 63 63
Numbness 44 44
Fluid Discharge 38 38
Muscle Weakness 38 38
Burning Sensation 34 34
Cramp(s) /Muscle Spasm(s) 30 30
Scar Tissue 29 29
Discomfort 26 26
Skin Erosion 25 25
Hypersensitivity/Allergic reaction 17 17
Hematoma 17 17
Fever 16 16
Twiddlers Syndrome 16 16
Swelling/ Edema 14 14
No Consequences Or Impact To Patient 12 12
Vomiting 12 12
Movement Disorder 12 12
Decreased Respiratory Rate 11 11
Nausea 9 9
Fall 9 9
Respiratory Arrest 8 8
Convulsion/Seizure 7 7
Shaking/Tremors 7 7
Chills 6 6
Seroma 6 6
Cardiac Arrest 6 6
Purulent Discharge 6 6
Skin Inflammation/ Irritation 6 6
Bacterial Infection 6 6
Hemorrhage/Bleeding 6 6
Pocket Erosion 6 6
Incontinence 5 5
Twitching 4 4
Aspiration/Inhalation 4 4
Paralysis 4 4
Urinary Retention 4 4

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