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TPLC
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Device
instrument, shunt system implantation
Product Code
GYK
Regulation Number
882.4545
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
2
2
2017
1
1
2020
1
1
2022
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
2
2
Break
2
2
Insufficient Information
1
1
Other (for use when an appropriate device code cannot be identified)
1
1
Device Or Device Fragments Location Unknown
1
1
Positioning Problem
1
1
Mechanical Jam
1
1
Device Packaging Compromised
1
1
Patient Device Interaction Problem
1
1
Device Operates Differently Than Expected
1
1
Bent
1
1
Difficult to Remove
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
Unknown (for use when the patient's condition is not known)
1
1
Low Oxygen Saturation
1
1
Confusion/ Disorientation
1
1
Diminished Pulse Pressure
1
1
No Patient Involvement
1
1
No Known Impact Or Consequence To Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Not Applicable
1
1
No Information
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Integra LifeSciences Corp.
II
Feb-14-2011
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