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

Model Number 27304

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2019

Event Type  Injury  

Event Description

During a lumbar drain placement, catheter met resistance.While trying to reposition the catheter and advance, it became clear that the catheter had become stuck and likely had sheared.As such, we removed the needle and catheter and confirmed that approx 4-5 cm of the catheter was retained in the pt.(b)(4).

• Brand Name: MEDTRONIC EDM LUMBAR DRAINAGE KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 9192371
• MDR Text Key: 162469490
• Report Number: MW5090367
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27304
• Device Lot Number: 217395078
• 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): Disability
• Patient Age: 72 YR
• Patient Weight: 82