MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46419
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient had a lumbar drain placed, but it was not internally anchored.On the fifth post-operative day, the drain was discontinued.While pulling the drain slowly, moderate resistance was met.With continued pulling, the drain was removed and the tip was noted to be sheared.A lumbar mri verified the retained catheter in the paraspinal musculature at the l4-l5 level.The patient returned to the operating room two days late for removal of the catheter fragment.The surgeon noted that the catheter did not appear to be entangled or anchored.An 18mm opaque catheter tip (fragment) was examined and noted to be torn at the site of the catheter perforation for drainage.

• Brand Name: EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8156579
• Report Number: 2021898-2018-00561
• Device Sequence Number: 1693483
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: 00613994806628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: D53292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention