MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CATHETER 46419 EDM LUMBAR 80CM W/TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46419
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Lumbar drain was attempted to be inserted.Upon removal of lumbar drain, tip was noted to not be intact.The lumbar drain tip retained in epidural space requiring urgent laminectomy.

• Brand Name: CATHETER 46419 EDM LUMBAR 80CM W/TIP
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 4620 north beach street; fort worth TX 76137
• MDR Report Key: 20609134
• Report Number: 20609134
• Device Sequence Number: 8144263
• Product Code: JXG
• UDI-Device Identifier: 00763000027285
• UDI-Public: (01)00763000027285
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/28/2024
• Report Date (Section F): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: CE0344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 10/28/2024