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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Definition Stimulation of nerves that innervate muscles to treat or aid in the management of chronic, intractable lower back pain.
Product CodeQLK
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 1 0 0 4 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 27 27
2023 58 58
2024 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 72 72
Failure to Conduct 68 68
Failure to Deliver Shock/Stimulation 7 7
Migration 6 6
Fracture 2 2
Electrical /Electronic Property Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Impedance Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 73 73
Implant Pain 39 39
No Clinical Signs, Symptoms or Conditions 18 18
Post Operative Wound Infection 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Urticaria 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Abrasion 1 1
Post Traumatic Wound Infection 1 1
Transient Ischemic Attack 1 1
Seroma 1 1
Neck Pain 1 1
Pain 1 1
Headache 1 1

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