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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)
2019 2020 2021 2022 2023 2024
0 1 0 0 4 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 27 27
2023 58 58
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Conduct 52 52
Adverse Event Without Identified Device or Use Problem 46 46
Failure to Deliver Shock/Stimulation 7 7
Migration 4 4
Appropriate Term/Code Not Available 1 1
Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Impedance Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 55 55
Implant Pain 26 26
No Clinical Signs, Symptoms or Conditions 16 16
Post Operative Wound Infection 7 7
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

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