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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN NEURO CODMAN CERTAS
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CODMAN NEURO CODMAN CERTAS Back to Search Results
Model Number REF 82-8851
Device Problem Self-Activation or Keying (1557)
Patient Problems Cerebral Ventriculomeglia (2133); No Code Available (3191)
Event Date 07/07/2015
Event Type  Injury  
Event Description
Child with codman certas valve shunt, underwent reprogramming on (b)(6) 2015 with codmans certas confirmation device as pressure level 2.Child experienced increased intracranial pressure.Symptoms began approximately 5 hours later, was taken to local emergency room and emergently flown by helicopter to this children's hospital.The confirmation device initially showed level 2, after repositioning child showed level 8 (which is off), confirmed by skull x-ray.The child was emergently tapped for csf and then the shunt was opened.The initial ct showed increased ventricle size.The child was admitted to the pediatric intensive care unit.The following day the ct showed the ventricles normalized.The child was discharged home after this potentially life threatening emergency.
 
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Brand Name
CODMAN CERTAS
Type of Device
CODMAN CERTAS
Manufacturer (Section D)
CODMAN NEURO
raynham ME 02767
MDR Report Key4924350
MDR Text Key22162533
Report NumberMW5044395
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberREF 82-8851
Device Catalogue NumberLCN 208079-001/A
Device Lot Number10AM1410A
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age3 YR
Patient Weight19
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