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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDMS EXACTA DRAINAGE SYSTEM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY EDMS EXACTA DRAINAGE SYSTEM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 46705
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problems Vomiting (2144); Loss of consciousness (2418)
Event Date 07/30/2014
Event Type  malfunction  
Event Description
Changing csf collection bag on evd with another rn, per policy & procedure.Pt's evd clamped for procedure.Difficult to unscrew connection between buritrol & collection bag.The connection snapped causing collection bag to fall off & buritrol system to need replaced which resulted in the pt's evd to remain clamped for 5-10 minutes.Patient began to vomit and became unresponsive.Attempted to arouse while waiting for neurosurg resident to come & reconnect drainage system.Condition c (code critical) initated.Neurosurg resident to bedside to reconnect evd drainage system.Pt began to become arousable once drain was unclamped by md.Notified charge rn and unit manager.No lasting harm.
 
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Brand Name
EDMS EXACTA DRAINAGE SYSTEM
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona dr
goleta CA 93117
MDR Report Key3986424
MDR Text Key4632195
Report Number3986424
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number46705
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2014
Event Location Hospital
Date Report to Manufacturer08/07/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age19 YR
Patient Weight58
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