MAUDE Adverse Event Report: MEDTRONIC EDM LUMBAR DRAIN KIT; SHUNT, CENTRAL NERVOUS SYSTEM COMPONENTS

Model Number 46420

Device Problems Failure to Advance (2524); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Headache (1880)

Event Date 01/26/2018

Event Type  Injury  

Event Description

A (b)(6) male with history of marfans syndrome.He was to undergo elective thoracoabdominal repair of his aorta for chronic type b dissection using deep hypothermic arrest and cardiopulmonary bypass.I work on the team as a cardiovascular anesthesiologist.Our approach involves preop insertion of a thoracic epidural catheter for postop analgesia and a lumbar spinal drain to monitor csf pressure and spinal cord perfusion pressure.These are done in the sitting position under light sedation.I have done thousands of spinal and epidurals in my career and hundreds of lumbar csf drain insertions.We use the medtronic edm lumbar drain kit no.(b)(4).I easily accessed the dura at l3/4 with clear csf withdrawing via the needle.I was unable to pass the silastic drain catheter beyond the tip of the needle.After several tries, 3 different dural punctures, and much lost csf, we abandoned the case and cancelled the procedure.One of my partners had a similar experience with the same catheter system the month before.However, he called me in to consult and with difficulty i was able to insert the csf drain in that instance.My patient was discharged home that afternoon, developed a severe postural headache - worse with sitting, standing or walking and relieved with bed rest.After three days at home with no improvement, he was re-admitted to our hospital.Internal medicine consult requested a lumbar puncture to exclude meningitis and this was performed by interventional radiology.Two days later, i performed an epidural blood patch with significant relief of his headache symptoms and he was discharged home.Unfortunately, he still must return for his aortic surgery, with lumbar csf drain insertion.Our plans is to wait a minimum of two weeks, then have this done by interventional radiology.I can find little information on lumbar csf drain insertion through recent epidural blood patch.My anesthesiologist partner and i am highly experienced and skilled with spinal and epidural access.We contend that there may be some change with the medtronic csf drain kit (no.(b)(4)) either in the silastic catheter or in the access needle contributing to this.It is our plan to switch immediately to a codman catheter that includes an insertion stylet to slightly stiffen the catheter and made it easier to pass the tip of the access needle.

• Brand Name: EDM LUMBAR DRAIN KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM COMPONENTS
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7244382
• MDR Text Key: 99215910
• Report Number: MW5075066
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 82