• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PS MEDICAL, INC. DRAIN EDM LUMBAR KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PS MEDICAL, INC. DRAIN EDM LUMBAR KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 46440
Device Problem Leak/Splash (1354)
Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage, Subdural (1894)
Event Date 01/14/2016
Event Type  malfunction  
Event Description
Surgery for thoracic abdominal aneurysm with lumbar drain placed prior to surgery. Post operative day 3 lumbar drain leaked csf (cerebral spinal fluid). Patient had a subdural hemorrhage with herniation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDRAIN EDM LUMBAR KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC PS MEDICAL, INC.
125 cremona drive
goleta, CA 93117
MDR Report Key5379184
MDR Text Key36354511
Report Number5379184
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number46440
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer01/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-