MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	41101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	01/22/2020
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 that after implantation of the product, the cerebral ventricle did not shrink, so the device was replaced with another manufacturer's device.The physician noted that when they checked the product at the time of removal, they confirmed that both the valve and catheter operated normally.It was indicated that the patient's status at the time of the report was alive-with injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned product was patent.20 inches of the catheter was returned.The catheter met the requirement for leakage testing.Dhr review of lot # e30694 did not indicate any deviation related to the complaint associated with the report.All products are 100% inspected at the time of packaging.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICULAR CATHETER, STANDARD, BARIUM IMPREGNATED, 23 CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9624878
• Report Number: 2021898-2020-00042
• Device Sequence Number: 14072229
• Product Code: JXG
• UDI-Device Identifier: 00643169466500
• UDI-Public: 00643169466500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 02/28/2022
• Device Model Number: 41101
• Device Catalogue Number: 41101
• Device Lot Number: E30694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/23/2020; 04/19/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/03/2020; 04/20/2020
• 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