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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device external cerebrospinal fluid (csf) diversion
Definition Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Product CodePCB
Regulation Number 882.5560
Device Class 2

MDR Year MDR Reports MDR Events
2023 8 8
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Cerebrospinal Fluid Leakage 6 6
Insufficient Information 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neurosurgery I Feb-27-2024
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