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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ventricular
Product CodeHCA
Regulation Number 882.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARKER HANNIFIN CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2017 3 3
2019 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Disconnection 1 1
Fracture 1 1
Difficult to Remove 1 1
Device Slipped 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fever 2 2
Unspecified Infection 2 2
Therapeutic Response, Decreased 2 2
Complaint, Ill-Defined 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Septic Shock 1 1
Hemorrhage, Intraventricular 1 1
Failure of Implant 1 1
Abnormal Blood Gases 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Apr-05-2021
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