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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


Premarket Reviews
ManufacturerDecision
MEDTRONIC NEUROSURGERY
  GRANTED 1

MDR Year MDR Reports MDR Events
2015 3 3
2018 3 3
2023 8 8
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 2 2
Break 2 2
Detachment Of Device Component 2 2
Component Falling 1 1
Failure to Disconnect 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
No Flow 1 1
Output Problem 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
No Known Impact Or Consequence To Patient 3 3
No Information 2 2
No Code Available 1 1
Insufficient Information 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1

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