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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
Regulation Description Central nervous system fluid shunt and components.
Product CodeLKG
Regulation Number 882.5550
Device Class 2

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2018 7 7
2019 4 4
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 4 4
Fracture 3 3
Break 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Tube 1 1
Hole In Material 1 1
Difficult to Remove 1 1
Catheter 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
Swelling 2 2
No Consequences Or Impact To Patient 1 1
Erosion 1 1
Cerebrospinal Fluid Leakage 1 1
Fatigue 1 1
Fever 1 1
Bacterial Infection 1 1
Death 1 1
Edema 1 1
Muscular Rigidity 1 1
Pain 1 1
Vomiting 1 1
Meningitis 1 1
No Information 1 1
No Code Available 1 1

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