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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 11

MDR Year MDR Reports MDR Events
2019 2549 2549
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1826 1826
2024 1876 1876

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3578 3578
Adverse Event Without Identified Device or Use Problem 2842 2842
Therapeutic or Diagnostic Output Failure 1943 1943
High impedance 1848 1848
Fracture 1299 1299
Insufficient Information 307 307
Material Fragmentation 271 271
Use of Device Problem 248 248
Wireless Communication Problem 236 236
Battery Problem 214 214
Impedance Problem 197 197
Disconnection 127 127
Patient-Device Incompatibility 112 112
Inappropriate/Inadequate Shock/Stimulation 107 107
Low impedance 78 78
Failure to Deliver Energy 70 70
Premature Elective Replacement Indicator 54 54
Break 49 49
No Apparent Adverse Event 46 46
Migration or Expulsion of Device 34 34
Therapy Delivered to Incorrect Body Area 32 32
Improper or Incorrect Procedure or Method 28 28
No Device Output 23 23
Separation Failure 23 23
Material Twisted/Bent 22 22
Material Split, Cut or Torn 20 20
Difficult to Remove 16 16
Temperature Problem 15 15
Unexpected Shutdown 14 14
Failure to Advance 13 13
Mechanical Jam 12 12
Pocket Stimulation 11 11
Difficult to Insert 9 9
Premature Discharge of Battery 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
Positioning Problem 3 3
High Readings 3 3
Energy Output Problem 3 3
Failure to Disconnect 3 3
Communication or Transmission Problem 3 3
Premature End-of-Life Indicator 2 2
Naturally Worn 2 2
Appropriate Term/Code Not Available 2 2
Entrapment of Device 2 2
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 9185 9185
Failure of Implant 733 733
No Clinical Signs, Symptoms or Conditions 715 715
Implant Pain 528 528
No Consequences Or Impact To Patient 516 516
Pain 294 294
Undesired Nerve Stimulation 236 236
Post Operative Wound Infection 228 228
Cerebrospinal Fluid Leakage 217 217
Unspecified Infection 176 176
Discomfort 155 155
Insufficient Information 138 138
Foreign Body In Patient 102 102
No Known Impact Or Consequence To Patient 92 92
Headache 89 89
Wound Dehiscence 86 86
Erosion 84 84
Device Embedded In Tissue or Plaque 80 80
Fall 76 76
Numbness 75 75
Muscle Weakness 47 47
Headache, Lumbar Puncture 40 40
Hematoma 38 38
Device Overstimulation of Tissue 32 32
Fever 31 31
Burning Sensation 29 29
Fluid Discharge 29 29
Scar Tissue 28 28
Vomiting 22 22
Cramp(s) /Muscle Spasm(s) 22 22
Weakness 20 20
Bacterial Infection 19 19
Skin Erosion 16 16
Nausea 16 16
Twiddlers Syndrome 16 16
Hypersensitivity/Allergic reaction 14 14
Death 13 13
Seroma 12 12
Decreased Respiratory Rate 12 12
Muscle Spasm(s) 11 11
Cramp(s) 10 10
Twiddlers Syndrome 10 10
Weight Changes 9 9
Impaired Healing 9 9
Cardiac Arrest 9 9
Purulent Discharge 9 9
Swelling 8 8
Movement Disorder 8 8
Therapeutic Effects, Unexpected 8 8
Swelling/ Edema 7 7

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