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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 4

MDR Year MDR Reports MDR Events
2020 2323 2323
2021 2304 2304
2022 1957 1957
2023 1825 1825
2024 2075 2075
2025 547 547

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 3484 3484
Therapeutic or Diagnostic Output Failure 1764 1764
Adverse Event Without Identified Device or Use Problem 1633 1633
High impedance 1623 1623
Fracture 1201 1201
Insufficient Information 297 297
Material Fragmentation 279 279
Use of Device Problem 274 274
Battery Problem 229 229
Wireless Communication Problem 221 221
Impedance Problem 166 166
Inappropriate/Inadequate Shock/Stimulation 105 105
Patient-Device Incompatibility 82 82
Disconnection 78 78
Low impedance 73 73
Failure to Deliver Energy 65 65
No Apparent Adverse Event 53 53
Break 48 48
Improper or Incorrect Procedure or Method 32 32
Therapy Delivered to Incorrect Body Area 29 29
Separation Failure 26 26
Material Twisted/Bent 21 21
Premature Elective Replacement Indicator 18 18
Material Split, Cut or Torn 17 17
Migration or Expulsion of Device 16 16
Temperature Problem 15 15
Difficult to Remove 13 13
Pocket Stimulation 13 13
Mechanical Jam 12 12
Failure to Advance 12 12
Unexpected Shutdown 10 10
Difficult to Insert 9 9
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 7887 7887
Failure of Implant 942 942
No Clinical Signs, Symptoms or Conditions 786 786
Implant Pain 579 579
No Consequences Or Impact To Patient 253 253
Undesired Nerve Stimulation 240 240
Post Operative Wound Infection 211 211
Pain 170 170
Cerebrospinal Fluid Leakage 153 153
Unspecified Infection 151 151
Insufficient Information 150 150
Foreign Body In Patient 146 146
Device Embedded In Tissue or Plaque 98 98
Wound Dehiscence 82 82
Discomfort 75 75
Headache 73 73
Erosion 66 66
No Known Impact Or Consequence To Patient 58 58
Numbness 51 51
Muscle Weakness 37 37
Fluid Discharge 35 35
Burning Sensation 29 29
Scar Tissue 28 28
Cramp(s) /Muscle Spasm(s) 23 23
Hematoma 22 22
Fever 18 18
Vomiting 16 16
Skin Erosion 16 16
Hypersensitivity/Allergic reaction 15 15
Bacterial Infection 14 14
Fall 13 13
Twiddlers Syndrome 12 12
Movement Disorder 12 12
Nausea 11 11
Swelling/ Edema 11 11
Headache, Lumbar Puncture 11 11
Seroma 10 10
Decreased Respiratory Rate 10 10
Cardiac Arrest 9 9
Device Overstimulation of Tissue 7 7
Purulent Discharge 7 7
No Information 7 7
Death 6 6
Skin Inflammation/ Irritation 6 6
Convulsion/Seizure 6 6
Twiddlers Syndrome 5 5
Sepsis 5 5
Respiratory Arrest 5 5
Swelling 5 5
Incontinence 5 5

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