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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device port & catheter, implanted, subcutaneous, intraventricular
Product CodeLKG
Regulation Number 882.5550
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 8 8
2022 6 6
2023 10 10
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 14 14
Break 11 11
Fracture 9 9
Complete Blockage 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Disconnection 1 1
Entrapment of Device 1 1
Defective Device 1 1
Difficult to Remove 1 1
Infusion or Flow Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Known Impact Or Consequence To Patient 4 4
Fever 2 2
Unspecified Tissue Injury 2 2
Death 1 1
Drug Resistant Bacterial Infection 1 1
No Code Available 1 1
Skin Inflammation/ Irritation 1 1
Inflammation 1 1
Pain 1 1
Convulsion/Seizure 1 1
Bacterial Infection 1 1
Erosion 1 1

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