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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 38 38

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 59 59
Failure to Conduct 58 58
Failure to Deliver Shock/Stimulation 7 7
Migration 5 5
Fracture 2 2
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 63 63
Implant Pain 33 33
No Clinical Signs, Symptoms or Conditions 17 17
Post Operative Wound Infection 12 12
Cramp(s) /Muscle Spasm(s) 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pain 1 1
Urticaria 1 1
Abrasion 1 1

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