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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 1

MDR Year MDR Reports MDR Events
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1826 1826
2024 2075 2075

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3307 3307
Therapeutic or Diagnostic Output Failure 1710 1710
Adverse Event Without Identified Device or Use Problem 1561 1561
High impedance 1537 1537
Fracture 1127 1127
Insufficient Information 288 288
Material Fragmentation 257 257
Use of Device Problem 245 245
Battery Problem 221 221
Wireless Communication Problem 202 202
Impedance Problem 158 158
Inappropriate/Inadequate Shock/Stimulation 103 103
Patient-Device Incompatibility 79 79
Disconnection 76 76
Low impedance 66 66
Failure to Deliver Energy 64 64
Break 48 48
No Apparent Adverse Event 46 46
Improper or Incorrect Procedure or Method 31 31
Therapy Delivered to Incorrect Body Area 29 29
Separation Failure 22 22
Material Twisted/Bent 19 19
Material Split, Cut or Torn 17 17
Premature Elective Replacement Indicator 17 17
Migration or Expulsion of Device 16 16
Temperature Problem 15 15
Difficult to Remove 13 13
Mechanical Jam 12 12
Failure to Advance 12 12
Pocket Stimulation 11 11
Unexpected Shutdown 10 10
Difficult to Insert 8 8
Intermittent Energy Output 7 7
Incomplete or Inadequate Connection 4 4
Failure to Disconnect 3 3
Premature Discharge of Battery 3 3
Material Separation 3 3
Energy Output Problem 3 3
Material Protrusion/Extrusion 2 2
Device Damaged by Another Device 2 2
Naturally Worn 2 2
Positioning Problem 2 2
Entrapment of Device 2 2
Material Frayed 2 2
Device Handling Problem 1 1
Charging Problem 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Device Contamination with Chemical or Other Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 7512 7512
Failure of Implant 786 786
No Clinical Signs, Symptoms or Conditions 736 736
Implant Pain 539 539
No Consequences Or Impact To Patient 253 253
Undesired Nerve Stimulation 235 235
Post Operative Wound Infection 197 197
Pain 164 164
Cerebrospinal Fluid Leakage 148 148
Unspecified Infection 142 142
Insufficient Information 141 141
Foreign Body In Patient 115 115
Device Embedded In Tissue or Plaque 82 82
Wound Dehiscence 77 77
Discomfort 75 75
Headache 68 68
Erosion 63 63
No Known Impact Or Consequence To Patient 58 58
Numbness 47 47
Muscle Weakness 36 36
Fluid Discharge 34 34
Burning Sensation 28 28
Scar Tissue 27 27
Hematoma 22 22
Cramp(s) /Muscle Spasm(s) 22 22
Fever 18 18
Vomiting 16 16
Skin Erosion 16 16
Bacterial Infection 14 14
Fall 13 13
Hypersensitivity/Allergic reaction 13 13
Nausea 11 11
Headache, Lumbar Puncture 11 11
Twiddlers Syndrome 10 10
Decreased Respiratory Rate 10 10
Seroma 10 10
Swelling/ Edema 9 9
Cardiac Arrest 9 9
Movement Disorder 9 9
No Information 7 7
Purulent Discharge 7 7
Device Overstimulation of Tissue 7 7
Convulsion/Seizure 6 6
Skin Inflammation/ Irritation 6 6
Death 6 6
Respiratory Arrest 5 5
Swelling 5 5
Twiddlers Syndrome 5 5
Incontinence 5 5
Twitching 4 4

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