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	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the lumbar catheter got cut off in a patient by the trocar.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the device remained in the patient; however, there was no injury to the patient.

• 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: 8346150
• Report Number: 2021898-2019-00053
• Device Sequence Number: 11271309
• Product Code: JXG
• UDI-Device Identifier: 00613994806628
• UDI-Public: 00613994806628
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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 Expiration Date: 10/31/2023
• Device Model Number: 46419
• Device Catalogue Number: 46419
• Device Lot Number: E57792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1