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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, shunt system implantation
Product CodeGYK
Regulation Number 882.4545
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 1 1
Mechanical Jam 1 1
Positioning Problem 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Apnea 2 2
Bradycardia 1 1
Keratitis 1 1
Paresis 1 1
Low Oxygen Saturation 1 1
Confusion/ Disorientation 1 1
Diminished Pulse Pressure 1 1
Not Applicable 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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