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

Model Number	46419
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Lumbar drain was being placed by dr.In interventional radiology.During the placement of the catheter, it broke off inside the patient during the adjustment of it.The separation (breakage) of the catheter happened just below the surface tissue of the back (maybe an inch?).Dr.1 attempted to retrieve it but was unable to.Being dr.2's patient, dr.1 consulted the situation with him and dr.2 and np proceeded to come to the biplane and help retrieve it and were successful.Every part of the catheter was retrieved and nothing was left in the patient.

• Brand Name: EDM LUMBAR CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7637353
• Report Number: 7637353
• Device Sequence Number: 14014345
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: (01)00613994806628(17)230228(10)E46362
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2018
• Report Date (Section F): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: E46362
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/14/2018