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

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.

• Brand Name: DRAIN EDM LUMBAR KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC PS MEDICAL, INC.; 125 cremona drive; goleta, CA 93117
• MDR Report Key: 5379184
• MDR Text Key: 36354511
• Report Number: 5379184
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 46440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR